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drug/enforcement
Terminated
Peoria
IL
United States
Class II
{}
Drugs
72241
Kalman Health & Wellness, Inc. dba Essential Wellness Pharma
4625 N University St
N/A
61614-5828
Voluntary: Firm initiated
Letter
Nationwide
D-321-2016
Progesterone 100 mg/mL in Corn Oil Injection, 2 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
1 vial
Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs.
20150903
20151117
20171229
20151125
Lot #: 072915, Exp 10/29/2015
2026-05-14T17:41:49.939Z
null
drug/enforcement
Ongoing
San Juan Del Rio
N/A
Mexico
Class II
{}
Drugs
86162
Albek De Mexico S.A. De C.V.
Oriente Cuatro No. 11 Nuevo
N/A
N/A
Voluntary: Firm initiated
Press Release
USA Nationwide
D-0080-2021
Assured Instant Hand Sanitizer Aloe & Moisturizers (Ethyl Alcohol 70% v/v) 8 fl oz / 237 mL bottle, Distributed By: Greenbrier International, Inc. 500 Volvo Parkway, Chesapeake, VA 23320. Made in Mexico.UPC 639277928610
27,000 bottles
CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.
20200730
20201117
null
20201125
1931102AL
2026-05-14T17:41:50.012Z
null
drug/enforcement
Ongoing
Exton
PA
United States
Class II
{}
Drugs
97808
ProRx LLC
619 Jeffers Cir
N/A
19341-2540
Voluntary: Firm initiated
Letter
TX and UT
D-0115-2026
Semaglutide Injection, 10 mg/4 mL (2.5 mg/mL), 4mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-04
8,400 vials
Lack of Assurance of Sterility
20251015
20251027
null
20251105
Lot, Best Use Date (BUD): Lot PRORX050925-1, BUD November 4, 2025; Lot ProRx051425-5, BUD November 10, 2025; Lot ProRx051425-6, BUD November 10, 2025
2026-05-14T17:41:50.051Z
null
drug/enforcement
Terminated
Parsippany
NJ
United States
Class II
{"application_number": ["ANDA040422"], "brand_name": ["DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE"], "generic_name": ["DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE"], "manufacturer_name": ["Teva Pharmac...
Drugs
85712
Teva Pharmaceuticals USA
400 Interpace Pkwy
N/A
07054-1120
Voluntary: Firm initiated
Letter
Nationwide within the United State and Puerto Rico.
D-1285-2020
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets ( Mixed Amphetamine Salts Product), 5 mg, 100 count bottles, Rx Only, Teva Pharmaceuticals USA, INC. North Wales, PA 19454, NDC 0555-0971-02
33,280 bottles
Some bottles may contain mixed strengths of the product.
20200522
20200604
20210525
20200610
Lot #: 42614718, Exp. date 02/2021
2026-05-14T17:41:50.097Z
null
drug/enforcement
Terminated
Allegan
MI
United States
Class II
{"application_number": ["M012"], "brand_name": ["EQUALINE NASAL"], "generic_name": ["OXYMETAZOLINE HCL"], "manufacturer_name": ["United Natural Foods, Inc. dba UNFI"], "product_ndc": ["41163-703"], "product_type": ["HUMAN OTC DRUG"], "route": ["NASAL"], "substance_name": ["OXYMETAZOLINE HYDROCHLORIDE"], "rxcui": ["1000...
Drugs
88905
Perrigo Company PLC
515 Eastern Ave
49010-9070
Voluntary: Firm initiated
Letter
Nationwide in the USA
D-0623-2022
No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle, Distributed by SUPERVALU INC., Eden Prairie, MN 55344 USA. NDC 41163-703-10
1,560 bottles
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
20211026
20220223
20230929
20220302
Batch: 1BK0964, Exp 01/31/2023
2026-05-14T17:41:50.135Z
drug/enforcement
Terminated
Lake Forest
IL
United States
Class II
{}
Drugs
74057
Pharmedium Services, LLC
150 N Field Dr Ste 350
N/A
60045-2506
Voluntary: Firm initiated
E-Mail
Nationwide
D-1398-2016
2 mcg/mL Fentanyl Citrate and 0.16% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 150 mL Baxter Intravia Bag, Service Code 2K8102, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-102-48
940 bags
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
20160505
20160716
20180306
20160727
Lot Number 160380168M , Exp. Date 5/8/2016 ; Lot Number 160410137M , Exp. Date 5/11/2016 ; Lot Number 160460150M , Exp. Date 5/16/2016 ; Lot Number 160530279M , Exp. Date 5/23/2016 ; Lot Number 160590185M , Exp. Date 5/29/2016 ; Lot Number 160630160M , Exp. Date 6/2/2016 ; Lot Number 160680179M , Exp. Date 6/7/20...
2026-05-14T17:41:50.169Z
drug/enforcement
Terminated
New York
NY
United States
Class III
{"application_number": ["NDA020779"], "brand_name": ["VIRACEPT"], "generic_name": ["NELFINAVIR MESYLATE"], "manufacturer_name": ["AGOURON"], "product_ndc": ["63010-010", "63010-027"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "route": ["ORAL"], "substance_name": ["NELFINAVIR MESYLATE"], "rxcui": ["212118", "311924",...
Drugs
68660
Pfizer Inc.
235 East 42nd Street
N/A
10017-5703
Voluntary: Firm initiated
Letter
Nationwide and Puerto Rico
D-1443-2014
VIRACEPT (R) (nelfinavir mesylate) Tablets, 625 mg, 120-count bottle, Rx only, Manufactured by: Agouron Pharmaceuticals, Inc. A Pfizer Company, Distributed by: ViV Healthcare Company, Research Triangle Park, NC 27709 NDC 63010-027-70
1200 tablets
Labeling: Incorrect or missing lot and or Exp Date: The bottles were labeled with an incorrect expiry date 11/2016. The correct expiry date is 09/2016.
20140708
20140717
20150706
20140723
Lot H45241, exp. 11/16
2026-05-14T17:41:50.215Z
null
drug/enforcement
Ongoing
Dania Beach
FL
United States
Class II
{}
Drugs
94788
Little Moon Essentials LLC
501 Old Griffin Rd
N/A
33004-2774
Voluntary: Firm initiated
Letter
Nationwide USA and Ontario, Canada (2 retailers)
D-0572-2024
Little Moon Essentials, Crampy Belly Rub (Camphor 1.1%), Packaged as a) 4 FL OZ (118ML) glass jar, UPC Code 6 73673 88260 2, NDC 70722-260-04; b) 2 FL OZ (59ML) glass jar, UPC Code 6 73673 88204 6, NDC 70722-260-02, Little Moon Essentials LLC Dania Beach, Fl 33004
788 glass jars
CGMP deviations
20240620
20240702
null
20240710
lot code No Expiration Date on product: a) 224010, b) 321260, 322260, 320280, 328080, 325021, 321121, 423010, 427110, 429120, 420220, 422140
2026-05-14T17:41:50.249Z
null
drug/enforcement
Terminated
Houston
TX
United States
Class II
{}
Drugs
81002
Pharm D Solutions, LLC
1304 S Loop W
N/A
77054-4010
Voluntary: Firm initiated
Press Release
Nationwide
D-0194-2019
Trimix QM10 Papaverine 30 mg/Phentolamine 4 mg/Atropine 1 mg/PGE 150 mcg/mL Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1352-05
9 vials
Lack of Assurance of Sterility
20180910
20181101
20210205
20181107
Lot: 04262018:09 Discard by: 10/22/2018; 07022018:48 Discard by: 12/29/2018
2026-05-14T17:41:50.286Z
null
drug/enforcement
Terminated
Chesterbrook
PA
United States
Class II
{}
Drugs
66316
AmeriSource Bergen
1300 Morris Dr
19087-5559
Voluntary: Firm initiated
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Nationwide
D-1066-2013
Ifosfamide Injection 3g/60 mL, Single dose vial, Rx only, Sterile, For Intravenous Use, Refrigerate at 2-8 degrees celcius, Distributed by Pfizer Labs, Division of Pfizer Inc., New York, NY 10017, NDC 0069-4496-22
60 vials
Temperature abuse: Certain vials of Ifosfamide IV products were not refrigerated at certain Amerisource Bergen Drug Corp distribution centers.
20130913
20130927
20141001
20131009
Lot #s: 7800929, 7800931, Exp 02/15; 7800962, Exp 03/15
2026-05-14T17:41:50.326Z
drug/enforcement
Terminated
Fountain Run
KY
United States
Class II
{}
Drugs
77601
Apace KY LLC
12954 Fountain Run Rd
N/A
42133-7914
Voluntary: Firm initiated
E-Mail
KY
D-1035-2017
Amantadine HCl Capsules, USP, 100 mg, Rx Only, 50 Capsules (5x10) Unit Dose Cartons, Manufactured for: AvKARE Inc, Pulaski, TN 38478 --- NDC: 50268-0069-15
1,483 cartons
Labeling; Label Mix up; cartons labeled as Amantadine HCl 100 mg Capsules contain unit dose blister cards of Cyclobenzaprine HCl Tablet, USP 5 mg
20170619
20170731
20180504
20170809
Lot: 16710, exp 07/2018
2026-05-14T17:41:50.364Z
null
drug/enforcement
Terminated
Dublin
OH
United States
Class II
{"application_number": ["NDA200796"], "brand_name": ["EDARBI"], "generic_name": ["AZILSARTAN KAMEDOXOMIL"], "manufacturer_name": ["Azurity Pharmaceuticals, Inc."], "product_ndc": ["60631-040", "60631-080"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "route": ["ORAL"], "substance_name": ["AZILSARTAN KAMEDOXOMIL"], "rx...
Drugs
87512
Cardinal Health Inc.
7000 Cardinal Pl
N/A
43017-1091
Voluntary: Firm initiated
Letter
FL, GA, SC
D-0429-2021
Edarbi (azilsartan medoxomil) tablets 80 mg 30 Tablets Rx Only NDC 60631-080-30 Manufactured for: arbor Pharmaceuticals Atlanta, GA 30328
328 bottles
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
20210315
20210524
20240617
20210602
78902-1
2026-05-14T17:41:50.410Z
null
drug/enforcement
Terminated
Knoxville
TN
United States
Class II
{}
Drugs
71371
The Compounding Pharmacy of America
6216 Highland Place Way Ste 101-A
37919-4068
Voluntary: Firm initiated
Telephone
Nationwide
D-1519-2015
HCG 1,100 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compounding Pharmacy of America, Knoxville, TN
1558 ml total
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
20150602
20150915
20160210
20150923
All lots distributed between November 2014 and May 2015; 05062015@32, 8/4/2015; 02272015@16, 5/28/2015; 03032015@33, 6/1/2015; 03042015@36, 6/2/2015; 03062015@43, 6/4/2015; 03092015@77, 6/7/2015; 03092015@92, 6/7/2015; 03132015@17, 11/2015; 03162015@23, 14/2015; 03172015@40, 5/2015; 03232015@39, 6/21/2015; 03242015@23...
2026-05-14T17:41:50.722Z
drug/enforcement
Terminated
Eatontown
NJ
United States
Class II
{}
Drugs
67022
West-Ward Pharmaceutical Corp.
465 Industrial Way W
N/A
07724-2209
Voluntary: Firm initiated
Letter
Nationwide
D-367-2014
Carisoprodol Tablets, USP 350 mg, Rx Only, 1000 tablets. Dist by: West-ward Pharmaceutical Corp. Eatontown, NJ 07724. Mfd by: Shasun Chemicals and Drugs Limited, Unit II, R. S. Na 32, 33, 743 PIMS Rd, Periyakalepet, Pondicherry. 605014 INDIA. NDC 0143-9749-10.
20,534 bottles
Presence of Foreign Substance; heavy metals (chromium, titanium etc) and inactive components of the product were visually observed during routine stability testing
20131107
20131216
20140814
20131225
NDC 0143-9749-10 Lot: 1) 10BR001B, Exp Aug-2014 2) 10BR002B, Exp Aug-2014 3) 10BR003B Exp, Aug-2014 4) 10BR004B Exp, Aug-2014 5) 10BR005B Exp, Aug-2014 6) 10BR006B Exp, Aug-2014 7) 11BR001B Exp, Aug-2014 8) 11BR002B Exp, Jul-2015 9) 11BR003B Exp, Jul-2015 10) 11BR004B Exp, Jul-2015 11) 11BR005B Exp, Jul-2015 12) 1...
2026-05-14T17:41:50.764Z
null
drug/enforcement
Terminated
Dublin
OH
United States
Class II
{"application_number": ["ANDA077857"], "brand_name": ["ENOXAPARIN SODIUM"], "generic_name": ["ENOXAPARIN SODIUM"], "manufacturer_name": ["Sandoz Inc"], "product_ndc": ["0781-3238", "0781-3246", "0781-3256", "0781-3262", "0781-3268", "0781-3298", "0781-3299"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "route": ["SUBC...
Drugs
89450
CARDINAL HEALTHCARE
7200 Cardinal Pl W
43017-1094
Voluntary: Firm initiated
Letter
Nationwide USA
D-0179-2024
Enoxaparin Sodium Injection, USP, 150MG/ML Single-Dose Syringes with Automatic Safety Device, For Subcutaneous Injection, Ten 1 mL Syringes per box, Rx Only, Sandoz Inc, Princeton, NJ 08540. NDC: 0781-3299-69
2 units
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
20220126
20231226
20240929
20240103
Batch SAH06821A
2026-05-14T17:41:50.798Z
drug/enforcement
Terminated
Olive Branch
MS
United States
Class I
{}
Drugs
80719
Westminster Pharmaceuticals LLC
1 & 2
154 Downing Street
38654
Voluntary: Firm initiated
Letter
Nationwide in the USA and Puerto Rico
D-1178-2018
Levothyroxine and Liothyronine (Thyroid Tablets, USP), 1 grain (60 mg), 100-count bottles, Rx Only, Manufactured for: Westminster Pharmaceuticals, LLC, 154 Downing Street, Unit 1 & 2, Olive Branch, MS 38654, NDC 69367-156-04.
Unknown
Failed Content Uniformity Specifications: Product was manufactured using an adulterated active pharmaceutical ingredient; additionally, lack of process controls and good manufacturing practices resulted in finished product failing content uniformity specifications which can result in a product having a strength that is...
20180803
20180907
20200603
20180829
Lot #: 15617VP03, 15617VP01, 15617VP-02, Exp 7/31/2019; 15617VP06, 15617VP05, Exp 11/30/2019; 15617VP04, 15618004, 15618002, Exp 12/31/2019; 15618009, 15618008, Exp 2/29/2020; 15618011, Exp 3/31/2020.
2026-05-14T17:41:50.874Z
drug/enforcement
Terminated
Boca Raton
FL
United States
Class II
{}
Drugs
78553
KRS Global Biotechnology, Inc
791 Park of Commerce Blvd Ste 600
N/A
33487-3633
Voluntary: Firm initiated
Letter
Nationwide in the USA, Bermuda, and New Zealand
D-0176-2018
Human Chorionic Gonadotropin 6,000 iu/Vial, For SC Use -Lyophilized, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
2,239 vials
Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
20171116
20180108
20200511
20180117
Lot: 08302017@11 BUD: 2/26/2018
2026-05-14T17:41:50.908Z
drug/enforcement
Terminated
Chesapeake
VA
United States
Class II
{}
Drugs
91466
Sentara Infusion Services
535 Independence Pkwy Ste 300
N/A
23320-5176
Voluntary: Firm initiated
Telephone
Dispensed to Patients Nationwide.
D-0296-2023
HYDROMORPHONE (a) 1MG/ML IN NS, 50ML, 75 ML, 100ML, 175ML(NDC 00703-0018-01 and NDC 00409-2634-50) ; (b) 5MG/ML IN NS 60ML, 100ML, 250ML; pain, Rx only, used with a Curlin pump or no pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320, NDC# 00409-2634-50
37 bags
Lack of sterility assurance
20221227
20230215
20260220
20230222
Beyond Use Date: December 24-31, 2022
2026-05-14T17:41:50.942Z
null
drug/enforcement
Terminated
Knoxville
TN
United States
Class II
{}
Drugs
71371
The Compounding Pharmacy of America
6216 Highland Place Way Ste 101-A
37919-4068
Voluntary: Firm initiated
Telephone
Nationwide
D-1744-2015
Testosterone 20 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN
24 pellets
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
20150602
20150915
20160210
20150923
All lots distributed between November 2014 and May 2015; 03032015@43, 8/30/2015
2026-05-14T17:41:50.983Z
drug/enforcement
Terminated
Vancouver
WA
United States
Class II
{}
Drugs
65707
Aidapak Services, LLC
14301 Se 1st St
98684-3501
Voluntary: Firm initiated
Telephone
Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
D-518-2014
FAMOTIDINE Tablet, 20 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 16714036104
700 Tablets
Labeling: Label Mixup; FAMOTIDINE Tablet, 20 mg may be potentially mislabeled as CARVEDILOL PHOSPHATE ER, Capsule, 20 mg, NDC 00007337113, Pedigree: W003225, EXP: 6/17/2014; DULoxetine HCl DR, Capsule, 20 mg, NDC 00002323560, Pedigree: W003506, EXP: 6/21/2014; FAMOTIDINE, Tablet, 20 mg, NDC 16714036104, Pedigree: ...
20130702
20140116
20140207
20140122
FAMOTIDINE Tablet, 20 mg has the following codes Pedigree: W003226, EXP: 6/17/2014; Pedigree: W003507, EXP: 6/21/2014; Pedigree: W003508, EXP: 6/21/2014; Pedigree: W003764, EXP: 6/26/2014; Pedigree: W003406, EXP: 6/19/2014.
2026-05-14T17:41:51.016Z
drug/enforcement
Terminated
Asbury Park
NJ
United States
Class II
{}
Drugs
78991
Flawless Beauty LLC
1215 Main St
N/A
07712-5940
Voluntary: Firm initiated
Press Release
Product was distributed U.S.A. nationwide.
D-0333-2018
Ling Zhi capsules
N/A
Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products sold individually or as part of multi-unit kits in accordance with Consent Decree of Permanent Injunction ordered by the United States District Court due to misbranding and unapproved new drugs pursuant t...
20180119
20180205
20180913
20180214
all lots
2026-05-14T17:41:51.048Z
null
drug/enforcement
Ongoing
Dawsonville
GA
United States
Class II
{}
Drugs
92054
Direct Rx
94 Worldwide Dr
30534-6828
Voluntary: Firm initiated
Letter
Nationwide in the USA
D-0508-2023
Alprazolam C-IV, 1 mg, packaged in a) 30 Tabs per bottle, NDC 72189-213-30; b) 60 Tabs per bottle, NDC 72189-213-60; Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534.
349 bottles
CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns at the manufacturer.
20230322
20230406
null
20230412
Lots: a) 03FE2318, Exp. 8/31/24; b) 27FE2315, 28FE2313, 02MA2306, 21SE2201, 16NO2216, 17NO2216, 24FA2314, Exp. 8/31/24; 17FE2203, 12AP2204, 17MA2205, Exp. 3/31/23; 21JU2206, 22JU2220, 12JY2206, Exp. 5/31/23; 10AU2209, Exp. 6/30/23; 14DE2215, Exp. 9/30/24; 05JA2304, 27JA2301, Exp. 11/30/24.
2026-05-14T17:41:51.081Z
drug/enforcement
Terminated
Brookhaven
NY
United States
Class II
{"application_number": ["ANDA090576"], "brand_name": ["NIZATIDINE"], "generic_name": ["NIZATIDINE"], "manufacturer_name": ["Amneal Pharmaceuticals LLC"], "product_ndc": ["60846-301"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "route": ["ORAL"], "substance_name": ["NIZATIDINE"], "rxcui": ["476872"], "spl_id": ["aedc4...
Drugs
85386
Amneal Pharmaceuticals of New York, LLC
50 Horseblock Rd
N/A
11719-9509
Voluntary: Firm initiated
Press Release
Nationwide
D-1253-2020
Nizatidine Oral Solution, 15 mg/mL (75 mg/5mL) USP 480 mL bottles, Rx Only Distributed by: Gemini Laboratories, LLC Bridgewater, NJ 08807 NDC 60846-301-15
11258 bottles
CGMP Deviations: potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA.
20200415
20200424
20210908
20200506
06598004A 04/2020 06599001A 12/2020 06599002A 12/2020
2026-05-14T17:41:51.120Z
null
drug/enforcement
Terminated
Lincoln
NE
United States
Class II
{}
Drugs
65422
Novartis Consumer Health
10401 Hwy 6
N/A
68517-9626
Voluntary: Firm initiated
Letter
Nationwide, Puerto Rico, Brazil and Panama
D-844-2013
Excedrin Migraine (Acetaminophen 250 mg, Aspirin (NSAID) 250 mg and Caffeine 65 mg), a) 2-count tablets packaged in pouches, Distributed by Novartis Consumer Health, Inc., Parsippany, NJ, NDC 0067 203 702 Foreign packaging: b) Excedrin Migrana (Acetaminophen 250 mg, Aspirin 250 mg and 65 mg Caffeine) 2-ct pouches. ...
10,624,000 pouches
Defective container: products are packaged in pouches which may not have been fully sealed
20130606
20130806
20141104
20130814
Lot # a) 10116809, Exp 5/13 Foreign: Lot #s b) 10115644 Exp 5/13; 10118226 Exp 5/13; 10118227 Exp 6/13; 10118228 Exp 6/13; 10121956 Exp 8/13 and 10121957 Exp 8/13
2026-05-14T17:41:51.153Z
null
drug/enforcement
Terminated
Toronto
Canada
Class II
{}
Drugs
70452
Attix Pharmaceuticals
184 Front St E
unit 801
N/A
Voluntary: Firm initiated
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Nationwide to compounding pharmacies and research organizations.
D-707-2015
Homatropine Methylbromide active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
940 grams
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
20141114
20150420
20151007
20150429
All lots repackaged and distributed between 01/05/12 to 02/12/15
2026-05-14T17:41:51.192Z
drug/enforcement
Terminated
Bolingbroke
GA
United States
Class I
{}
Drugs
86270
SG24 LLC
8315 Rivoli Road
Ste A
31004
Voluntary: Firm initiated
Press Release
Nationwide
D-1572-2020
SkinGuard 24 All-Day Hand Sanitizer 8 oz. bottle with foam pump, Dist by: SG24 LLC, Bolingbroke, GA 31004 UPC 793573147125
9600 bottles
Marketed without an Approved NDA/ANDA; product labeled to contain 0.56% methanol making it an unapproved new drug
20200814
20200911
20230605
20200909
SKU 051230024 All lots labeled to contain methanol
2026-05-14T17:41:51.224Z
null
drug/enforcement
Terminated
Houston
TX
United States
Class II
{}
Drugs
82941
Pharm D Solutions, LLC
1304 S Loop W
N/A
77054-4010
FDA Mandated
Press Release
Nationwide within the United States
D-1325-2019
Human Chorionic Gonadotropin 5,000 IU vials, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846
279 vials
Lack of Sterility Assurance.
20190523
20190607
20210205
20190619
Lot #: 01082019:88 Exp. 07/06/2019; 03182019:58 Exp. 09/14/2019
2026-05-14T17:41:51.270Z
null
drug/enforcement
Ongoing
Hattiesburg
MS
United States
Class II
{}
Drugs
90982
Pharmacy Plus, Inc. dba Vital Care Compounder
115 S 40th Ave
N/A
39402-6600
Voluntary: Firm initiated
Telephone
AL, LA, MS, and TN
D-0037-2023
MEDROXYPROGESTERONE ACETATE 300 MG/ML Suspension, 10 mL vial, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
40 vials
Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
20221007
20221102
null
20221109
Lot: 55786, BUD: 12/31/2022
2026-05-14T17:41:51.323Z
null
drug/enforcement
Terminated
Norwalk
CT
United States
Class II
{}
Drugs
91719
Ecometics, Inc.
19 Concord St
06854-3706
Voluntary: Firm initiated
Letter
Nationwide within the United States
D-0452-2023
Unguentine Original Maximum Strength Pain Relieving/Antiseptic Ointment (Camphor 3.0%, Phenol 2.5%, Tannic Acid 2.2%, Oxide 6.6%), packaged in 1 oz. (28.3g) metal tubes, Distributed by: Oakhurst Company Levittown, NY 11756
CGMP DEVIATIONS
20230224
20230308
20230621
20230315
Lot #: 1E346A, Exp. Date Nov-23; 2E304A, Exp. Date Oct-24
2026-05-14T17:41:51.362Z
drug/enforcement
Ongoing
Parsippany
NJ
United States
Class III
{"application_number": ["ANDA072695"], "brand_name": ["NORTREL"], "generic_name": ["NORETHINDRONE AND ETHINYL ESTRADIOL"], "manufacturer_name": ["Teva Pharmaceuticals USA, Inc."], "product_ndc": ["0555-9008", "0555-9009", "0555-9010"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "rxcui": ["310463", "312033", "748797",...
Drugs
93867
Teva Pharmaceuticals USA, Inc
400 Interpace Pkwy Bldg A
N/A
07054-1120
Voluntary: Firm initiated
Letter
nationwide
D-0321-2024
Nortrel (norethindrone and ethinyl estradiol tablets USP) 0.5/35, packaged in cartons, each carton contains 3 blister cards, each card contains 28 tablets, Rx only, TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC 0555-9008-67
12,916 cartons
Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.
20240125
20240212
null
20240221
Lot #: 100042978, Exp 7/31/2024
2026-05-14T17:41:51.398Z
null
drug/enforcement
Terminated
Toronto
Canada
Class II
{}
Drugs
70452
Attix Pharmaceuticals
184 Front St E
unit 801
N/A
Voluntary: Firm initiated
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Nationwide to compounding pharmacies and research organizations.
D-790-2015
Methyl Folate Calcium active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
5 grams
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
20141114
20150420
20151007
20150429
All lots repackaged and distributed between 01/05/12 to 02/12/15
2026-05-14T17:41:51.456Z
drug/enforcement
Ongoing
Bengaluru
N/A
India
Class II
{"application_number": ["ANDA209101"], "brand_name": ["HALOPERIDOL DECANOATE"], "generic_name": ["HALOPERIDOL DECANOATE"], "manufacturer_name": ["BluePoint Laboratories"], "product_ndc": ["68001-578", "68001-579", "68001-580", "68001-581", "68001-582"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "route": ["INTRAMUSCU...
Drugs
96569
Somerset Therapeutics Private Limited
54/1 Budihal Village
N/A
N/A
Voluntary: Firm initiated
Letter
U.S. Nationwide
D-0356-2025
Haloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured by: Somerset Therapeutics Limited, Kamataka India, Manufactured for: BluePoint Laboratories NDC 68001-580-41
4956 vials
Lack of Assurance of Sterility: Media fill with bacterial contamination
20250321
20250408
null
20250416
A240467B, exp. date 07/2026
2026-05-14T17:41:51.500Z
null
drug/enforcement
Terminated
Los Angeles
CA
United States
Class II
{}
Drugs
84978
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
1990 Westwood Blvd Ste 135
N/A
90025-4650
Voluntary: Firm initiated
Press Release
U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic
D-0960-2020
Polyoxyl Lauryl Ether (Polidocanol) Injection, LAURETH-9 (POLIDOCANOL) 5% INJECTABLE, For IV Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-060-3
N/A
Lack of Assurance of Sterility
20200115
20200305
20231207
20200311
Lot #: 10152019+53126, Exp 4/6/2020
2026-05-14T17:41:51.543Z
null
drug/enforcement
Ongoing
Parsippany
NJ
United States
Class II
{}
Drugs
83050
Teva Pharmaceuticals USA
400 Interpace Pkwy
07054-1120
Voluntary: Firm initiated
E-Mail
Nationwide by 4 major distributors.
D-1455-2019
LOSARTAN POTASSIUM 50 mg TABLET BULK 90 count bottles and 1000 count bottles, NDC 00591-3746-00
2,924,000 tablets
CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
20190606
20190709
null
20190717
Arrow Malta (Teva) Bulk Product Lot # 1169752A, exp. date 01/2020, 1000 tablets/bottle 1169753A, exp. date 01/2020, 90 tablets/bottle Golden State Medical Finished Product Lot # GS017387, exp. date 01/2020 GS017651, exp. date 01/2020 GS017479, exp. date 01/2020
2026-05-14T17:41:51.584Z
drug/enforcement
Terminated
Boca Raton
FL
United States
Class II
{}
Drugs
78553
KRS Global Biotechnology, Inc
791 Park of Commerce Blvd Ste 600
N/A
33487-3633
Voluntary: Firm initiated
Letter
Nationwide in the USA, Bermuda, and New Zealand
D-0165-2018
Benzocaine 20%, Lidocaine 6%, Tetracaine 4% Cream packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
4,530 jars
Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
20171116
20180108
20200511
20180117
Lots: 06072017@22 BUD: 12/4/2017; 06222017@30 BUD: 12/19/2017; 08032017@31 BUD: 1/30/2018; 09212017@21 BUD: 3/20/2018; 10232017@20 BUD: 11/22/2017
2026-05-14T17:41:51.622Z
drug/enforcement
Terminated
IRVING
TX
United States
Class II
{"application_number": ["NDA216632"], "brand_name": ["CABTREO"], "generic_name": ["CLINDAMYCIN PHOSPHATE/BENZOYL PEROXIDE/ADAPALENE"], "manufacturer_name": ["Bausch Health US LLC"], "product_ndc": ["0187-0006"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "route": ["TOPICAL"], "substance_name": ["ADAPALENE", "BENZOYL ...
Drugs
94023
MCKESSON CORPORATION
6555 NORTH STATE HIGHWA
N/A
75039
Voluntary: Firm initiated
E-Mail
Nationwide in the US
D-0347-2024
CABTREO (clindamycin phosphate, adapalene and benzoyl peroxide) Topical Gel 1.2%/0.15%/3.1%, Not for Oral, Ophthalmic or Intravaginal Use, Rx Only, Net Wt. 50g, Distributed by Bausch Health US, LLC Bridgewater, NJ 08807 USA, Manufactured by: Bausch Health Companies, Inc. Laval Quebec H7L 448, Canada, NDC 0187-0006-25.
42 units
CGMP Deviations: Product was stored outside labeled storage temperature requirements. Product was exposed to controlled room temperature environment instead of remaining refrigerated.
20240212
20240222
20241001
20240228
Lot: 7001796, Exp 05/31/2025
2026-05-14T17:41:51.657Z
null
drug/enforcement
Ongoing
Boca Raton
FL
United States
Class II
{}
Drugs
97369
GenoGenix LLC
2840 Nw 2nd Ave Ste 204
33431-6692
Voluntary: Firm initiated
Letter
US Nationwide.
D-0081-2026
Reconstitution XO Solution for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for CELIA Health a) 5% Exosomes, 10 mL vial and b) 10% Exosomes, 5 mL vial, Extension Health a) 20% Exosomes, 10 mL vial, b) 10% Exosomes, 10 mL vial...
Lack of Assurance of Sterility
20250730
20251021
null
20251015
All lots within expiry.
2026-05-14T17:41:51.713Z
drug/enforcement
Terminated
Lake Forest
IL
United States
Class II
{}
Drugs
78828
Pharmedium Services, LLC
150 N Field Dr Ste 350
N/A
60045-2506
Voluntary: Firm initiated
Press Release
U.S.A. Nationwide
D-0454-2018
Glycopyrrolate in all strengths, all doses, and all packaging.
Unknown
Lack of sterility assurance.
20171227
20180220
20200507
20180228
All lots remaining within expiry.
2026-05-14T17:41:51.748Z
null
drug/enforcement
Terminated
Little Rock
AR
United States
Class II
{}
Drugs
77770
SCA Pharmaceuticals
8821 Knoedl Ct
N/A
72205-4600
Voluntary: Firm initiated
Letter
Nationwide
D-1027-2017
PHENYLephrine 40 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0812-40
N/A
Lack of Assurance of Sterility; product has the potential to leak.
20170714
20170726
20190501
20170802
Lots: 20170429@28 BUD: 7/28/2017; BUD: 20170509@65 BUD: 8/7/2017
2026-05-14T17:41:51.785Z
null
drug/enforcement
Terminated
Dublin
OH
United States
Class II
{"application_number": ["NDA205649"], "brand_name": ["XIGDUO"], "generic_name": ["DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE"], "manufacturer_name": ["AstraZeneca Pharmaceuticals LP"], "product_ndc": ["0310-6225", "0310-6270", "0310-6280", "0310-6250", "0310-6260"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "route": ...
Drugs
87512
Cardinal Health Inc.
7000 Cardinal Pl
N/A
43017-1091
Voluntary: Firm initiated
Letter
FL, GA, SC
D-0435-2021
xigduo XR (dapgliflozin/metformin HCl extended-release) tablets 10 mg/1000 mg 30 Tablets Rx only NDC 0310-6280-30 Manufactured for: AstraZeneca Pharmaceuticals LP Wilmington, DE 19850 Manufactured by: Bristol-Myers Squibb Manufacturing Company Humacao, Puerto Rico 00791
664 bottles
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
20210315
20210524
20240617
20210602
MP0077
2026-05-14T17:41:51.818Z
null
drug/enforcement
Completed
Aquebogue
NY
United States
Class II
{}
Drugs
83265
Altaire Pharmaceuticals, Inc.
311 W Ln
PO Box 849
11931-0849
Voluntary: Firm initiated
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
U.S.A. Nationwide
D-0394-2020
CVS Health Redness Relief Lubricant Redness Reliever Eye Drops, Sterile, 1 fl. oz., (30 mL), Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895
N/A
Lack of Assurance of Sterility
20190702
20191115
null
20191127
Lot #: 18229 9/21 18229 9/21 19056 03/22
2026-05-14T17:41:51.851Z
null
drug/enforcement
Terminated
Highland
NY
United States
Class II
{}
Drugs
89334
ULTRAtab Laboratories, Inc.
50 Toc Dr
N/A
12528-1506
Voluntary: Firm initiated
Letter
Bulk product was distributed to 3 distributors who may have distributed finished product.
D-0536-2022
APAP 500 mg tablet (Acetaminophen 500 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-210-00
6,249,082 tablets
CGMP Deviations
20220126
20220209
20250107
20220216
Product Codes: L210L Bulk Lots: 18L120, 19B044, 19E082
2026-05-14T17:41:51.893Z
null
drug/enforcement
Terminated
Augusta
GA
United States
Class II
{}
Drugs
64661
Clinical Specialties Compounding Pharmacy
318 Baston Rd
N/A
30907
Voluntary: Firm initiated
Telephone
FL, GA and SC.
D-662-2013
Progesterone 50 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907
637ml total
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
20130320
20130703
20170222
20130710
Lot number CABDBFAC:48, Exp date: 5/17/2014; and Lot number CABDCEAB:14, Exp date: 4/25/2014.
2026-05-14T17:41:51.927Z
null
drug/enforcement
Terminated
Dublin
OH
United States
Class III
{"application_number": ["BLA761061"], "brand_name": ["TREMFYA"], "generic_name": ["GUSELKUMAB"], "manufacturer_name": ["Janssen Biotech, Inc."], "product_ndc": ["57894-640", "57894-650", "57894-651"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "route": ["SUBCUTANEOUS"], "substance_name": ["GUSELKUMAB"], "rxcui": ["19...
Drugs
87489
Cardinal Health Inc.
7000 Cardinal Pl
43017-1091
Voluntary: Firm initiated
Letter
AL, LA, MS, TN
D-0314-2021
Tremfya (guselkumab) Injection, 100 mg/mL, one single-dose prefilled syringe per carton, Rx only, Manufactured by: Janssen Biotech, Inc., Horsham, PA 19044; NDC 57894-640-01.
48 boxes
Temperature Abuse
20210309
20210329
20211104
20210407
KESOY.AI Exp. 04/2022
2026-05-14T17:41:51.954Z
drug/enforcement
Terminated
Asheville
NC
United States
Class I
{}
Drugs
80601
King Bio Inc.
3 Westside Dr
N/A
28806-2846
Voluntary: Firm initiated
Press Release
U.S.A. Nationwide, Canada, and Australia.
D-0580-2019
Dr. King's Natural Medicine Homeopathic Hydration, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806, UPC 357955024224, NDC 57955-0242-2
38 bottles
Microbial contamination
20180720
20190308
20220119
20190320
Lot Numbers: 041816A Exp. 04/19; 070816E Exp. 07/19
2026-05-14T17:41:51.994Z
null
drug/enforcement
Terminated
Columbus
OH
United States
Class III
{}
Drugs
71634
American Health Packaging
2550 John Glenn Ave
Suite A
43217-1188
Voluntary: Firm initiated
Letter
U.S. Nationwide
D-1235-2015
Desmopressin Acetate Tablets, 0.1 mg Tablets, Rx Only, Packed in 30 Tablet (3 x 10) Cartons. Packaged and Distributed by: American Health Packaging Columbus, Ohio 43217. NDC: 68084-606-21.
341 Cartons
Tablets/Capsules Imprinted with Wrong ID: Some tablets incorrectly imprinted with an X on one side.
20150626
20150714
20180815
20150722
Lot #:151360, Expiry: 12/31/2016
2026-05-14T17:41:52.023Z
drug/enforcement
Terminated
Vicksburg
MS
United States
Class II
{}
Drugs
79748
Kroger Specialty Pharmacy, Inc.
100 Pear Orchard Dr Ste A
N/A
39180-7153
Voluntary: Firm initiated
Letter
MS, LA, AR, IL, FL
D-0796-2018
Zarxio 300 mcg/0.5 mL PFS NDC 14 days supply
Unknown
Lack of Processing Controls.
20180403
20180510
20200507
20180516
All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018
2026-05-14T17:41:52.066Z
null
drug/enforcement
Terminated
Somerset
NJ
United States
Class III
{"application_number": ["ANDA203602"], "brand_name": ["MORPHINE SULFATE"], "generic_name": ["MORPHINE SULFATE"], "manufacturer_name": ["Lupin Pharmaceuticals,Inc."], "product_ndc": ["43386-540", "43386-541", "43386-542", "43386-543", "43386-544"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "route": ["ORAL"], "substan...
Drugs
82581
LUPIN SOMERSET
400 Campus Dr
N/A
08873-1145
Voluntary: Firm initiated
Letter
Product was shipped to 5 wholesalers and one Supermarket Chain who may have further distributed the product throughout the United States.
D-1245-2019
Morphine Sulfate Extended-Release Tablets, 60 mg, 100-count bottles, Rx Only, Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 NDC 43386-542-01
10,284 bottles
Failed Impurities/Degradation Specifications
20190410
20190425
20221014
20190501
Lot#: S700222 Exp. Apr 30 2019 ; S800233 Exp, Feb 29 2020
2026-05-14T17:41:52.106Z
null
drug/enforcement
Ongoing
Chesapeake
VA
United States
Class II
{}
Drugs
90566
Family Dollar Stores, Llc.
500 Volvo Pkwy
23320-1604
Voluntary: Firm initiated
Other
Nationwide within the United States
D-1461-2022
QP COUGH COLD TABLET 16 CT distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
Unknown
CGMP Deviations: product held outside appropriate storage temperature conditions.
20220623
20220822
null
20220831
SKU: 916922
2026-05-14T17:41:52.141Z
drug/enforcement
Terminated
Brooksville
FL
United States
Class II
{}
Drugs
64188
TG United, Inc.
16275 Aviation Loop Dr
N/A
34604-6805
Voluntary: Firm initiated
Letter
FL, MS, SC, LA and TX
D-509-2013
AMBI 2CPM/15DM/5PEH, Antihistamine, Nasal Decongestant, Fruit Candy Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0228-16.
355 - 16 ounce bottles
CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
20130130
20130604
20160930
20130612
Lot # 12DQ004, Exp. 03/14.
2026-05-14T17:41:52.161Z
null
drug/enforcement
Terminated
Newtown
PA
United States
Class III
{}
Drugs
71726
KVK-Tech, Inc.
110 Terry Dr
N/A
18940-3427
Voluntary: Firm initiated
Letter
Nationwide
D-1371-2015
Phentermine Hydrochloride Capsules, USP, 15 mg, packaged in a) 100-count bottle (NDC 10702-0026-01; UPC 3 10702 02601 8) and b) 1000-count bottle (NDC 10702-0026-10; UPC 3 10702 02601 0); Rx only, Mfd. by KVK-TECH, Inc., Newtown, PA
9,696 bottles (100-count), 972 bottles (1000-count)
Failed Impurities/Degradation Specifications: out-of-specification results for individual unknown and total impurity at the 12th month room temperature stability test station
20150714
20150825
20170113
20150902
Lot #: a) 11957A, Exp 04/2017; b) 11956A, Exp 04/2017
2026-05-14T17:41:52.201Z
null
drug/enforcement
Terminated
Las Vegas
NV
United States
Class II
{}
Drugs
79619
Partell Specialty Pharmacy
5835 S Eastern Ave Ste 101
89119-3031
Voluntary: Firm initiated
Letter
NV only
D-0666-2018
Testosterone 40 mg pellet packaged in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
20180322
20180417
20190115
20180425
Lot#: 20171214@90, BUD 06/12/2018; 20171113@81, BUD 05/12/2018; 20180220@58, BUD 08/19/2018.
2026-05-14T17:41:52.230Z
drug/enforcement
Terminated
Worcester
MA
United States
Class II
{}
Drugs
82538
Lohxa LLC
600 Main St Ste 110
N/A
01608-2061
Voluntary: Firm initiated
Letter
MA, NY and WY
D-1130-2019
Bismuth Subsalicylate Oral Suspension 262mg/15mL, unit dose cups, OTC, Rpkg. By.: Lohxa Worcester, MA, NDC 70166-059-01
5 boxes - 250 unit dose cups.
Labeling: Incorrect or Missing Lot and/or Exp Date - the label contains an incorrect Exp Date.
20190325
20190415
20230620
20190417
Lot#: M030042P, Exp. 01/2020
2026-05-14T17:41:52.270Z
null
drug/enforcement
Terminated
Birmingham
AL
United States
Class II
{}
Drugs
74466
Medaus, Inc.
6801 Cahaba Valley Rd Ste 116
35242-9609
Voluntary: Firm initiated
E-Mail
U.S. Nationwide, Japan, and New Zealand.
D-1222-2016
M.I.C B-COMPLEX PREMIX W/HYDROXY B12 W/PRES. (BENZALKONIUM 0.01%) HYDROXY B12 1MG; B1 0.833MG; B2 0.083MG; B3 0.833MG, B5 0.083MG, B6 0.083MG, CYANO B12 1.66MCG, METHIONINE 0.208MG, INOSITOL 0.416MG, CHOLINE CL 1.66MG/ML, 10ML Vials, MEDAUS PHARMACY
110 mL in Vials
Lack of Assurance of Sterility
20160513
20160708
20170616
20160720
Lot #: 160229-24, BUD: 07/25/16, Lot #: 160315-5, BUD: 07/25/16
2026-05-14T17:41:52.306Z
drug/enforcement
Terminated
Brooklyn
NY
United States
Class II
{}
Drugs
83136
Infusion Options, Inc.
5924 13th Ave
N/A
11219-4934
Voluntary: Firm initiated
Letter
NY only
D-1786-2019
INJECTAFER 720 MG in 100 ml NS IVPB; INJECTAFER 210 MG in 100 ml NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
N/A
Lack of Assurance of Sterility
20190612
20190815
20250321
20190821
All lots within expiry
2026-05-14T17:41:52.340Z
null
drug/enforcement
Terminated
Dublin
OH
United States
Class II
{"application_number": ["NDA207932"], "brand_name": ["BELBUCA"], "generic_name": ["BUPRENORPHINE HYDROCHLORIDE"], "manufacturer_name": ["BioDelivery Sciences International Inc"], "product_ndc": ["59385-021", "59385-022", "59385-023", "59385-024", "59385-025", "59385-026", "59385-027"], "product_type": ["HUMAN PRESCRIPT...
Drugs
87512
Cardinal Health Inc.
7000 Cardinal Pl
N/A
43017-1091
Voluntary: Firm initiated
Letter
FL, GA, SC
D-0448-2021
Belbuca (buprenorphine hydrochloride) buccal film 300 mcg 60 pouches containing 1 buccal film each Rx only NDC 59385-023-60 Manufactured for: BioDelivery Sciences International, Inc. Raleigh, NC 27612.
96 cartons
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
20210315
20210524
20240617
20210602
37674B
2026-05-14T17:41:52.371Z
null
drug/enforcement
Terminated
Waterford
MI
United States
Class II
{}
Drugs
79149
American Pharmaceutical Ingredients LLC
6650 Highland Rd Ste 302
N/A
48327-1665
Voluntary: Firm initiated
Letter
Nationwide within USA.
D-0513-2018
Nifedipine USP for prescription compounding, packaged in a) 5g (NDC 58597-8025-2); b) 25g (NDC 58597-8025-4); c) 100g (NDC 58597-8025-6); d) 500g (NDC 58597-8025-7), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
44500 g
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
20180209
20180222
20191202
20180228
Lot #: a) 020615-2, Exp. 12/04/2018; b) 020615-2, Exp. 12/04/2018; c) 020615-1, Exp. 12/04/2018; d) 020615-1, Exp. 12/04/2018; 020615-2, Exp. 12/04/2018.
2026-05-14T17:41:52.403Z
null
drug/enforcement
Terminated
Vancouver
WA
United States
Class II
{}
Drugs
65690
Aidapak Services, LLC
14301 Se 1st St
98684-3501
Voluntary: Firm initiated
Telephone
Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
D-871-2014
FLUCONAZOLE, Tablet, 200 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00172541360.
200 Tablets
Labeling: Label Mixup: FLUCONAZOLE, Tablet, 200 mg may have potentially been mislabeled as one of the following drugs: VALSARTAN, Tablet, 80 mg, NDC 00078035834, Pedigree: AD65475_10, EXP: 5/28/2014; FLUCONAZOLE, Tablet, 100 mg, NDC 68462010230, Pedigree: W003064, EXP: 6/12/2014.
20130702
20140120
20140207
20140129
FLUCONAZOLE, Tablet, 200 mg has the following codes: Pedigree: AD65475_16, EXP: 5/28/2014; Pedigree: W003065, EXP: 6/12/2014.
2026-05-14T17:41:52.441Z
drug/enforcement
Terminated
Baltimore
MD
United States
Class II
{"application_number": ["ANDA065259"], "brand_name": ["CEFDINIR"], "generic_name": ["CEFDINIR"], "manufacturer_name": ["Lupin Pharmaceuticals, Inc."], "product_ndc": ["68180-722", "68180-723"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "route": ["ORAL"], "substance_name": ["CEFDINIR"], "rxcui": ["309054", "476576"],...
Drugs
81888
Lupin Pharmaceuticals Inc.
111 S Calvert St Fl 21ST
21202-6174
Voluntary: Firm initiated
Letter
Nationwide within the United States
D-0375-2019
Cefdinir for Oral Suspension USP, 125mg/5mL, packaged in a) 60mL (NDC 68180-722-20), b)100mL (NDC 68180-722-10), Rx Only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, MD 21202; Manufactured by: Lupin Limited Mandideep 462 046 INDIA
287,784 bottles
CGMP Deviations: Product complaints received indicating reconstituted suspension was observed to be thick.
20190102
20190115
20200626
20190116
a) Lot #: F700329, F700330, F700328, Exp. January 2019; F700544, F700545, F700668, F700669, F700670, Exp. March 2019; F700958, Exp. April 2019 b) Lot #: F700327, F700392, F700393, Exp. January 2019; F700546, F700547, F700664, Exp. March 2019; F700967, Exp. April 2019, F701106, F701107, F701108, F701109, Exp. May 201...
2026-05-14T17:41:52.461Z
drug/enforcement
Terminated
Lake Forest
IL
United States
Class II
{"application_number": ["ANDA077548"], "brand_name": ["ONDANSETRON"], "generic_name": ["ONDANSETRON"], "manufacturer_name": ["Hospira, Inc."], "product_ndc": ["0409-4755", "0409-4759"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "route": ["INTRAMUSCULAR", "INTRAVENOUS"], "substance_name": ["ONDANSETRON HYDROCHLORIDE"...
Drugs
65300
Hospira, Inc.
600 N Field Dr Bldg J45
N/A
60045
Voluntary: Firm initiated
Letter
Nationwide
D-851-2013
Ondansetron Injection, USP, 4mg/2mL, (2mg/ml), 2mL single-dose Fliptop Vial, Rx only, Sterile, NDC 0409-4755-03, Hospira, Inc, Lake Forest, IL 60045.
340,600 vials
Presence of Particulate; lot being recalled as a precaution due to the discovery of 2 particles found in a lot which preceded the recalled lot
20130520
20130807
20141028
20130814
Lot 25394DK, exp. 01/2015
2026-05-14T17:41:52.510Z
null
drug/enforcement
Terminated
Houston
TX
United States
Class II
{}
Drugs
76561
Advanced Pharma Inc.
9265 Kirby Dr
77054-2520
Voluntary: Firm initiated
E-Mail
U.S. Nationwide
D-0831-2017
Succinylcholine Chloride all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
20170222
20170523
20171018
20170531
all lots within expiry
2026-05-14T17:41:52.546Z
drug/enforcement
Terminated
Newbern
TN
United States
Class II
{}
Drugs
65479
Main Street Family Pharmacy, LLC
126 East Main Street
N/A
38059
Voluntary: Firm initiated
Telephone
nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV
D-241-2014
Mic Ultra-Sulfur Free 30ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
115 units
The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials.
20130528
20131203
20140422
20131211
all codes distributed prior to and including 05/23/2013
2026-05-14T17:41:52.576Z
null
drug/enforcement
Terminated
Aurora
IL
United States
Class II
{}
Drugs
71535
the Compounder
340 Marshall Ave Unit 100
N/A
60506-5649
Voluntary: Firm initiated
Telephone
Nationwide
D-0204-2016
BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) : PROG (Progesterone USP Micronized) : TESTO (Testosterone USP) : DHEA (Dehydroepiandrosterone Micronized) W/V (weight/volume) VERSABASE 2.5 : 17.5 : 1.25 :0.25MG/ML Transdermal cream, dispensed in 10 mL prefilled, amber syringes, Rx only,The Co...
12 (10mL) syringes
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
20150310
20151110
20160519
20151118
Lot # 01152015:68@24, Exp 7/14/2015; and Lot # 02192015:15@12, Exp 8/18/2015
2026-05-14T17:41:52.618Z
null
drug/enforcement
Ongoing
East Brunswick
NJ
United States
Class II
{"application_number": ["ANDA079106"], "brand_name": ["BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE"], "generic_name": ["BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE"], "manufacturer_name": ["Unichem Pharmaceuticals (USA), Inc."], "product_ndc": ["29300-187", "29300-188", "29300-189"], "product_type": ["HUMAN PRESCRIPTIO...
Drugs
98323
Unichem Pharmaceuticals USA Inc.
1 Tower Center Blvd Ste 2200
N/A
08816-1145
Voluntary: Firm initiated
Letter
US Nationwide and PR.
D-0301-2026
Bisoprolol Fumarate and Hydrochlorothiazide tablets, USP, 2.5 mg/6.25 mg, 100-count bottle, Rx Only, Manufactured by: UNICHEM LABORATORIS LTD., Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511, India, Manufactured for: UNICHEM PHARMACEUTICALS (USA), INC., East Brunswick, NJ 08816, NDC 29300-187-01
N/A
cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits.
20260121
20260130
null
20260211
Lot # GBHL24005A, Exp Date: 09/2026
2026-05-14T17:41:52.635Z
null
drug/enforcement
Terminated
Windsor
CT
United States
Class II
{}
Drugs
92737
SCA Pharmaceuticals
755 Rainbow Rd Ste B
N/A
06095-1024
Voluntary: Firm initiated
Letter
KY and NJ
D-0945-2023
FentaNYL 500 mcg/250 mL - Bupivacaine HCl 0.1% in 0.9% Sodium Chloride 250mL Bag, Injection for Epidural Use (fentaNYL Concentration - 2 mcg/mL), Rx Only, Single Dose Container, SCA Pharmaceuticals, 755 Rainbow Rd, Windsor, CT 06095, NDC# 70004-0253-40
183 bags
cGMP deviations: due to shipment of rejected units.
20230720
20230726
20230921
20230802
Lot # 1223047134, Use By: 09/21/2023
2026-05-14T17:41:52.684Z
null
drug/enforcement
Terminated
South San Francisco
CA
United States
Class II
{"application_number": ["BLA103172"], "brand_name": ["CATHFLO ACTIVASE"], "generic_name": ["ALTEPLASE"], "manufacturer_name": ["Genentech, Inc."], "product_ndc": ["50242-041"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "route": ["INTRAVENOUS"], "substance_name": ["ALTEPLASE"], "spl_id": ["0c2938dd-2978-411f-bd76-208...
Drugs
94653
Genentech, Inc.
1 Dna Way Bldg 5
94080-4918
Voluntary: Firm initiated
Letter
Nationwide within the United States
D-0509-2024
Cathflo activase (ALTEPLASE), 2mg vials, Rx only, Genentech Inc., South San Francisco, CA 94080, NDC 50242-041-64
Lot:3618858 = 105,759; Lot:3618873 =90,359
Lack of Assurance of Sterility: Deformed stoppers observed during filling operations for Cathflo Activase.
20240520
20240524
20250811
20240605
Lot #: 3618858, 3618873, Exp. Date 01/31/2026
2026-05-14T17:41:52.741Z
drug/enforcement
Terminated
Chattanooga
TN
United States
Class I
{}
Drugs
89138
Aroma Release Technologies Inc
7026 Discovery Dr
37416-1692
Voluntary: Firm initiated
Letter
Distributed in the states of Texas and New York.
D-0298-2022
Klean Touch Hand Sanitizer (Ethyl Alcohol 70%) Ingredients Ethanol and Methanol, in 55-gallon drums, Aroma Release Technology, Inc., 7026 Discovery Drive, Chattanooga, TN 37416
37 55-gallon drums
Marketed Without an Approved NDA/ANDA: Product labeled to contain methanol making it an unapproved new drug and contains methanol
20211130
20211228
20240315
20220105
Lots: 1620-1, 1620-3, 1620-4, 1820-4, 1820-5, 1920-1, 1920-2, No Expiration Date
2026-05-14T17:41:52.780Z
drug/enforcement
Ongoing
Fair Lawn
NJ
United States
Class II
{}
Drugs
91427
Fisher Scientific Co., LLC
1 Reagent Ln
N/A
07410-2802
Voluntary: Firm initiated
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Nationwide in the USA
D-0163-2023
Hand Sanitizer, HSANI500ML, (Isopropyl Alcohol), 75% v/v, packaged in a) 500 mL bottle and b) 6 x 500 mL bottles per case, Thermo Fisher Scientific: Janssen Pharmaceuticalaan 3a, 2440 Geel - Belgium, 1 Reagent Lane, Fair Lawn, NJ 07410.
a) 1077 bottles, b) 52 cases
CGMP Deviations: Voluntary recall of all hand sanitizer distributed after March 31, 2022, due to FDA issued guidance to cease placing hand sanitizer product, produced under temporary approval, into the market after March 31, 2022.
20230117
20230118
null
20230125
Lot Numbers: 202160, 202162, 202324, 202368, 202369, 202593, 202594, 202835, 202862, 202863, 202865, 202836, 202864, 203061, 203098, 203099, 203100, 203101, 203102, 203236, 203237, 203239, 203337, 203338, 203335, 203336
2026-05-14T17:41:52.825Z
null
drug/enforcement
Terminated
Vancouver
WA
United States
Class II
{}
Drugs
65707
Aidapak Services, LLC
14301 Se 1st St
98684-3501
Voluntary: Firm initiated
Telephone
Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
D-653-2014
VITAMIN B COMPLEX WITH C/FOLIC ACID, Tablet, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 60258016001
600 Tablets
Labeling:Label Mixup; VITAMIN B COMPLEX WITH C/FOLIC ACID, Tablet may be potentially mislabeled as LEVOTHYROXINE SODIUM, Tablet, 88 mcg, NDC 00378180701, Pedigree: AD73652_10, EXP: 5/30/2014; HYOSCYAMINE SULFATE ER, Tablet, 0.375 mg, NDC 43199001401, Pedigree: W003576, EXP: 6/24/2014; MELATONIN, Tablet, 3 mg, NDC ...
20130702
20140116
20140207
20140122
VITAMIN B COMPLEX WITH C/FOLIC ACID, Tablet has the following codes Pedigree: AD73652_19, EXP: 5/30/2014; Pedigree: W003591, EXP: 6/24/2014; Pedigree: AD70655_17, EXP: 5/28/2014; Pedigree: W003361, EXP: 6/19/2014.
2026-05-14T17:41:52.846Z
drug/enforcement
Terminated
Monterey Park
CA
United States
Class II
{}
Drugs
83437
Herbal Doctor Remedies
497 Cumbre St
N/A
91754-2114
Voluntary: Firm initiated
N/A
Nationwide within the United States and Brazil and on the internet
D-1613-2019
Prostatin Capsules, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
N/A
CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.
20190712
20190802
20230613
20190814
All lots within expiry
2026-05-14T17:41:52.889Z
null
drug/enforcement
Terminated
San Antonio
TX
United States
Class II
{}
Drugs
88862
Vita Pharmacy, LLC dba Talon Compounding Pharmacy
2950 Thousand Oaks Dr Ste 25
N/A
78247-3347
Voluntary: Firm initiated
Telephone
United States including Washington, D.C. and Puerto Rico
D-0106-2022
B COMPLEX INJ CMP-NO B12, NO LIDOCAINE INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
1 vial
Lack of assurance of sterility
20211012
20211108
20231004
20211117
Lot: 07192021:91 BUD: 10/17/2021
2026-05-14T17:41:52.908Z
drug/enforcement
Terminated
Asheville
NC
United States
Class I
{}
Drugs
80601
King Bio Inc.
3 Westside Dr
N/A
28806-2846
Voluntary: Firm initiated
Press Release
U.S.A. Nationwide, Canada, and Australia.
D-0709-2019
Dr. King's SafeCare Rx UlcerPlex, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive, Asheville, NC 28806 USA, UPC 357955175025, NDC 57955-0188-2
24 bottles
Microbial contamination
20180720
20190308
20220119
20190320
Lot: 010418D Exp. 01/20
2026-05-14T17:41:52.946Z
null
drug/enforcement
Terminated
San Antonio
TX
United States
Class II
{}
Drugs
88862
Vita Pharmacy, LLC dba Talon Compounding Pharmacy
2950 Thousand Oaks Dr Ste 25
N/A
78247-3347
Voluntary: Firm initiated
Telephone
United States including Washington, D.C. and Puerto Rico
D-0104-2022
ALPROSTADIL 40MCG/ML INJ 40MCG/ML INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
4 vials
Lack of assurance of sterility
20211012
20211108
20231004
20211117
Lot: 06242021:37 BUD: 10/22/2021; 08132021:74 BUD: 12/11/2021; 07132021:94 BUD:10/23/2021
2026-05-14T17:41:52.989Z
drug/enforcement
Terminated
Baltimore
MD
United States
Class III
{"application_number": ["ANDA208061"], "brand_name": ["TESTOSTERONE"], "generic_name": ["TESTOSTERONE"], "manufacturer_name": ["Lupin Pharmaceuticals, Inc."], "product_ndc": ["68180-943"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "route": ["TOPICAL"], "substance_name": ["TESTOSTERONE"], "rxcui": ["1599949"], "spl_i...
Drugs
82392
Lupin Pharmaceuticals Inc.
111 S Calvert St Fl 21ST
N/A
21202-6174
Voluntary: Firm initiated
Letter
Recalled product was distributed to 7 major wholesale/drug chain distributors and 1 supermarket chain that may have further distribute the product throughout the United States.
D-1010-2019
Testosterone Topical Solution, 30mg/1.5mL, 110mL bottles, Rx only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, Maryland 21202 United States, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775 INDIA, NDC 68180-943-11
3,200 bottles
Defective Container: Repetitive complaints received indicating pump not working.
20190313
20190319
20200626
20190327
Lot # K700086, Exp 11/2019
2026-05-14T17:41:53.028Z
null
drug/enforcement
Terminated
Plattsburgh
NY
United States
Class II
{}
Drugs
90653
SterRx, LLC
141 Idaho Ave
12903-3987
Voluntary: Firm initiated
Letter
Nationwide within the United States
D-1332-2022
fentaNYL Citrate in 0.9% Sodium Chloride, 2.5 mg per 250 mL, (10 mcg per mL) IV bags, Rx Only, SterRx, 141 Idaho Avenue, Plattsburgh, NY 12903, NDC 70324-327-02.
360 bags
Lack of Assurance of Sterility
20220725
20220809
20230622
20220817
Lot #: CHL, Exp. Date Dec 29, 2022
2026-05-14T17:41:53.063Z
drug/enforcement
Terminated
Wilsonville
OR
United States
Class II
{}
Drugs
69519
Oregon Compounding Centers, Inc. dba Creative Compounds
8560 Sw Salish Ln Ste 100
N/A
97070-9625
Voluntary: Firm initiated
Press Release
Oregon, Washington
D-0200-2015
HYDROXYPROGESTERONE CAPROATE (SESAME OIL), 250mg/mL, injectable, 5 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
520 mL
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
20141006
20141031
20150630
20141112
Lot #: 20140718@1/5, discard date: 1/14/2015; Lot #: 20140813@25, discard date: 2/9/2015; Lot #: 20140903@32, discard date: 3/2/2015.
2026-05-14T17:41:53.084Z
null
drug/enforcement
Terminated
Phoenix
AZ
United States
Class II
{}
Drugs
92898
Central Admixture Pharmacy Services, Inc.
2200 S 43rd Ave
N/A
85043-3909
Voluntary: Firm initiated
Letter
Nationwide in the USA
D-1131-2023
EPINEPHrine added to dextrose 5%, 4mg/250ml (16 mcg/mL), IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-7018-1.
554 bags
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
20230817
20230828
20250327
20230906
Lot# 36-262162, 36-262163, Exp 10/5/2023. ;
2026-05-14T17:41:53.110Z
null
drug/enforcement
Terminated
Birmingham
AL
United States
Class II
{}
Drugs
74466
Medaus, Inc.
6801 Cahaba Valley Rd Ste 116
35242-9609
Voluntary: Firm initiated
E-Mail
U.S. Nationwide, Japan, and New Zealand.
D-1224-2016
M.I.C 25/50/50 W/PRES. (BENZYL ETOH 2%) METHIONINE 25MG;INOSITOL 50MG;CHOLINE CHL 50/MG/ML, In a) 5ML Vials and b) 10ML Vials, MEDAUS PHARMACY
500 mL in Vials
Lack of Assurance of Sterility
20160513
20160708
20170616
20160720
a) Lot #: 160107-17, BUD: 07/05/16. b) Lot #: 160107-17, BUD: 07/05/16.
2026-05-14T17:41:53.147Z
drug/enforcement
Terminated
Brewerton
NY
United States
Class I
{}
Drugs
61256
www.vitaminbestbuy.com
6001 McKinley Rd.
N/A
13029
Voluntary: Firm initiated
E-Mail
Nationwide
D-1700-2012
Japan Weight Loss Blue Capsules, 9 g (300 mg), 30 count box, Green algae lipotropic (fat dissolving) agent, OTC, Distributed by Vitaminbestbuy.com, Brewerton, NY
52 boxes
Marketed Without an Approved ANDA/NDA: presence of sibutramine
20120223
20120926
20181101
20121003
All lots.
2026-05-14T17:41:53.166Z
drug/enforcement
Terminated
Windsor
CT
United States
Class II
{}
Drugs
93456
SCA Pharmaceuticals, LLC
755 Rainbow Rd Ste B
N/A
06095-1024
Voluntary: Firm initiated
Letter
Nationwide in the USA
D-0417-2024
PHENYLephrine HCl 5000 mcg/50 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 50 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0810-22, Bar Code 70004081022.
5,948 syringes, expanded 2,102 syringes
Lack of Assurance of Sterility
20231109
20240322
20240827
20240403
Lot #: 1223045282 Exp 11/24/23; 1223045370 Exp 11/26/23; 1223045624 Exp 12/07/23; 1223045723 Exp 12/10/23; 1223045732 Exp 12/10/23; 1223046128 Exp 12/24/23; 1223046133 Exp 12/24/23; 1223047112 Exp 02/02/24; 1223047232 Exp 2/07/24; 1223047398 Exp 02/15/24; 1223047456 Exp 02/16/24; 1223047569 Exp 02/18/24; 1223047694 Exp...
2026-05-14T17:41:53.197Z
drug/enforcement
Terminated
Temple Terrace
FL
United States
Class II
{}
Drugs
88394
BayCare Integrated Service Center, LLC /dba BayCare Central Pharmacy
7802 E Telecom Pkwy
33637-0928
Voluntary: Firm initiated
E-Mail
FL
D-0702-2021
Succinylcholine Chloride 100 mg/5 mL (20 mg/mL), 5 mL Syringes, Rx only, For IV Use only, BayCare Central Pharmacy, 7802 E. Telecom Parkway, Temple Terrace, FL 33837
253 syringes
Lack of sterility assurance
20210730
20210804
20211022
20210811
Lot: SUCC10020210624 Exp. 09/22/2021
2026-05-14T17:41:53.237Z
drug/enforcement
Terminated
Chicago
IL
United States
Class II
{}
Drugs
77959
Bella Pharmaceuticals, Inc.
3101 W Devon Ave
N/A
60659-1407
Voluntary: Firm initiated
Telephone
Nationwide within USA
D-1154-2017
L-Glutamine 100mg, 30 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA.
5 vials
Lack of Assurance of Sterility.
20170815
20170912
20180423
20170920
Lot #: BPLG08517, Exp. 2/5/18
2026-05-14T17:41:53.270Z
null
drug/enforcement
Terminated
Staten Island
NY
United States
Class I
{}
Drugs
76644
A&H Focal Inc.
119 Linwood Ave
10305-4445
Voluntary: Firm initiated
Press Release
NY and NJ through six retail stores named "Asian Food Markets"
D-0563-2018
Zhonghua Niubian tablets, 2000mg, 6-count bottle, labeling is in foreign language
unknown
Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.
20170307
20180228
20190614
20180207
All Lots
2026-05-14T17:41:53.290Z
drug/enforcement
Terminated
Lake Mary
FL
United States
Class II
{}
Drugs
64957
Axium Healthcare Pharmacy dba Balanced Solutions Compounding
550 Technology Park Ste 1008
32746-7131
Voluntary: Firm initiated
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
CO, GA, MI, and Puerto Rico
D-282-2013
Trimix Customs Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
61 vials (5 mL and 10 mL vials)
Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
20130417
20130423
20170419
20130501
ALL Lots
2026-05-14T17:41:53.312Z
drug/enforcement
Terminated
Chicago
IL
United States
Class II
{}
Drugs
77959
Bella Pharmaceuticals, Inc.
3101 W Devon Ave
N/A
60659-1407
Voluntary: Firm initiated
Telephone
Nationwide within USA
D-1152-2017
Methylcobalamin 10mg, (10mg/ml), 30 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA.
7 vials
Lack of Assurance of Sterility.
20170815
20170912
20180423
20170920
Lot #: BPMC30072917, Exp. 1/29/18
2026-05-14T17:41:53.334Z
null
drug/enforcement
Terminated
Ocala
FL
United States
Class II
{}
Drugs
75289
Wells Pharmacy Network LLC
1210 SW 33rd Ave
N/A
34474-2853
Voluntary: Firm initiated
Press Release
Nationwide
D-0337-2017
Alprostadil 20 mcg/mL Injectable, a) 5 mL and b) 10 mL vials, Compounded by Wells Pharmacy Network LLC, Ocala FL
a) 24 vials, b) 91 vials
Lack of Assurance of Sterility
20160921
20170104
20210702
20170111
All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. a) Known lot code: 03312016@6 b) Known lot code: 04222016@8, 15202016@85, 06302016@4, 08012016@32
2026-05-14T17:41:53.371Z
null
drug/enforcement
Terminated
Melbourne
FL
United States
Class II
{}
Drugs
83702
Pacifico National, Inc. dba AmEx Pharmacy
1515 Elizabeth St Ste J
32901-3000
Voluntary: Firm initiated
Press Release
Continental U.S. and Puerto Rico
D-1849-2019
Bevacizumab, 2.5 mg/0.1 mL, Norm-Ject Syringe Intravitreal Injection, Single use only, Rx only, Repackaged by AmEx Pharmacy 1515 Elizabeth St. Suite J Melbourne, FL 32901
Lack of assurance of sterility.
20190830
20190910
20201008
20190918
All lots remaining within expiry.
2026-05-14T17:41:53.401Z
drug/enforcement
Terminated
Corvallis
OR
United States
Class II
{}
Drugs
82278
Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy
996 Nw Circle Blvd Ste 105
N/A
97330-1485
Voluntary: Firm initiated
Telephone
Dispensed in Oregon
D-1110-2019
PAPAVERINE-PHENTOLAMINE-PGE1 17.44-0.64MG-5.8MCG/ML* INJECTABLE, 5 ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330 .
1 prescription, 5ml injection
Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
20190221
20190409
20200723
20190417
Lot:13092018@44, distributed between 09-01-2018 to 02-20-2019.
2026-05-14T17:41:53.436Z
null
drug/enforcement
Terminated
East Windsor
NJ
United States
Class III
{"application_number": ["ANDA077691"], "brand_name": ["SIMVASTATIN"], "generic_name": ["SIMVASTATIN"], "manufacturer_name": ["Aurobindo Pharma Limited"], "product_ndc": ["65862-050", "65862-051", "65862-052", "65862-053", "65862-054"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "route": ["ORAL"], "substance_name": ["...
Drugs
83436
Aurobindo Pharma USA Inc.
279 Princeton Hightstown Rd
N/A
08520-1401
Voluntary: Firm initiated
Letter
Product was distributed nationwide by three major distributors who may have further distributed the product.
D-1842-2019
Simvastatin Tablets, USP 40 mg. Rx Only 1000 Count Bottles Manufactured by: Aurolife Pharma LLC Dayton NJ 08810 Manufactured for: Aurobindo Pharma USA, Inc. Dayton, NJ 08810 NDC 65862-053-99
2,352/1000 count bottles
Labeling; Incorrect or Missing Lot and/or Exp Date; some bottles labeled with lot number 05318054B instead of 05318034B
20190729
20190826
20211028
20190904
05318054B, exp 3/2021
2026-05-14T17:41:53.469Z
null
drug/enforcement
Terminated
Brooklyn
NY
United States
Class II
{}
Drugs
83136
Infusion Options, Inc.
5924 13th Ave
N/A
11219-4934
Voluntary: Firm initiated
Letter
NY only
D-1746-2019
Adcetris 96 MG/100 ML NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
N/A
Lack of Assurance of Sterility
20190612
20190815
20250321
20190821
All lots within expiry
2026-05-14T17:41:53.489Z
null
drug/enforcement
Terminated
Lincoln
NE
United States
Class II
{}
Drugs
65490
Novartis Consumer Health
10401 Hwy 6
68517-9626
Voluntary: Firm initiated
Letter
Nationwide, Mexico, Russia, Korea, Panama, China, and Canada.
D-759-2014
NeoCitran Extra Strength Cold & Flu (acetaminophen 650 mg, phenylephrine hydrochloride 10 mg, pheniramine maleate 20 mg) powder packets, Natural Source Lemon flavor, 10-count single dose pouches per carton, Novartis Consumer Health Canada, Inc., Mississauga , ON, UPC 0 58478 05103 1. Also packaged under foreign labe...
Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
20130618
20140117
20141104
20140129
Lot #: 10113888, Exp 5/31/2013; 10118944, Exp 6/30/2013; 10120024, Exp 9/30/2013; 10124381, Exp 10/31/2013. Russia product: 10112623, 10112625, 10112627, 10112629, 10112631, 10112633, Exp 5/31/2013; 10116051, 10116053, 10116055, 10116057, 10116059, 10116061,10117302, 10117304, Exp 7/31/2013; 10119732, 10119735, Exp ...
2026-05-14T17:41:53.521Z
drug/enforcement
Terminated
Monterey Park
CA
United States
Class II
{}
Drugs
85341
Herbal Doctor Remedies
497 Cumbre St
N/A
91754-2114
Voluntary: Firm initiated
Other
Products are sold online within the United States and internationally to the following countries: Australia, Canada, Israel, Italy, Japan, Norway, and United Kingdom
D-1122-2020
Edema Off, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
N/A
CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
20200324
20200407
20240125
20200415
All lots within expiry
2026-05-14T17:41:53.585Z
null
drug/enforcement
Terminated
La Vergne
TN
United States
Class II
{}
Drugs
92524
The Harvard Drug Group
341 Mason Rd
N/A
37086-3606
Voluntary: Firm initiated
Letter
Nationwide in the U.S.
D-0878-2023
Tramadol Hydrochloride Tablets, USP 50 mg, Unit Dose 100-Count Tablets Rx only, Manufactured by: Sun Pharmaceutical Industries Ltd. Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), India. Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Distributed by: Major Pharmaceuticals Livonia, MI 48152 U...
3876 cartons
Packaging defect: blister packaging inadequately sealed.
20230616
20230626
20240430
20230705
Lot #: M04343, Exp. 04/2024
2026-05-14T17:41:53.603Z
drug/enforcement
Terminated
Erie
PA
United States
Class II
{}
Drugs
91332
Pharmacy Innovations
2936 W 17th St
N/A
16505-3929
Voluntary: Firm initiated
Telephone
Nationwide in the USA
D-0210-2023
GLUTATHIONE L REDUCED 100MG/ML (2ML NEBVL) INHALATION; GLUTATHIONE L REDUCED 200MG/ML (1ML NEBVL) INHALATION; GLUTATHIONE L REDUCED 220MG/ML (30ML VIAL) INJECTABLE; GLUTATHIONE L REDUCED 500MG/ML (1ML VIAL) INJECTABLE; GLUTATHIONE L REDUCED 500MG/ML (2ML VIAL) INJECTABLE; GLUTATHIONE L REDUCED-PF- 200MG/ML (2ML VIAL) I...
N/A
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
20221222
20230126
20240731
20230201
t20221129@68 t20221025@32 t20221025@33 t20221114@27 t20221021@40 t20221116@36
2026-05-14T17:41:53.637Z
drug/enforcement
Terminated
Parsippany
NJ
United States
Class II
{"application_number": ["ANDA201089"], "brand_name": ["DICLOFENAC SODIUM AND MISOPROSTOL"], "generic_name": ["DICLOFENAC SODIUM AND MISOPROSTOL"], "manufacturer_name": ["Actavis Pharma, Inc."], "product_ndc": ["0591-0397", "0591-0398"], "product_type": ["HUMAN PRESCRIPTION DRUG"], "route": ["ORAL"], "substance_name": [...
Drugs
66380
Actavis Inc
400 Interpace Pkwy
07054-1120
Voluntary: Firm initiated
Letter
Nationwide
D-1060-2014
Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75mg/0.2mg, Rx only, Manufactured by Watson Laboratories, Inc., Corona, CA 92880, NDC 0591-0398-60 (60 count bottles)
6,540 bottles
Failed Tablet/Capsule Specifications: Broken tablets
20130322
20140203
20150226
20140212
Lot 668271A, Exp 11/14 and Lot 684119A Exp 01/2015
2026-05-14T17:41:53.661Z
drug/enforcement
Ongoing
Mahwah
NJ
United States
Class II
{"application_number": ["ANDA078427"], "brand_name": ["CETIRIZINE HCL"], "generic_name": ["CETIRIZINE"], "manufacturer_name": ["GLENMARK THERAPEUTICS INC., USA"], "product_ndc": ["72657-128", "72657-129", "72657-130", "72657-131"], "product_type": ["HUMAN OTC DRUG"], "route": ["ORAL"], "substance_name": ["CETIRIZINE HY...
Drugs
96474
Glenmark Pharmaceuticals Inc., USA
750 Corporate Dr
N/A
07430-2009
Voluntary: Firm initiated
Letter
U.S. Nationwide
D-0348-2025
Cetirizine Hydrochloride Tablets, USP, 10mg, 365-count packs, Rx Only, Manufactured for: Glenmark Therapeutics Inc., Distributed by: Amazon. NDC# 72657-129-35
N/A
CGMP Deviations
20250313
20250408
null
20250416
Lot # 17231980, ep.. date Aug-25 Amazon 17232044, ep.. date Aug-25 Walmart 17241436, ep.. date Jul-26 Amazon 17241437, ep.. date Jul-26 Amazon 17241455, ep.. date Jul-26 Amazon 17241456, ep.. date Aug-26 Amazon 17241457, ep.. date Aug-26 Amazon 17241892, ep.. date Oct-26 Amazon 17241893, ep.. date Oct-26 Amazon
2026-05-14T17:41:53.691Z
null
drug/enforcement
Terminated
Asheville
NC
United States
Class I
{}
Drugs
80601
King Bio Inc.
3 Westside Dr
N/A
28806-2846
Voluntary: Firm initiated
Press Release
U.S.A. Nationwide, Canada, and Australia.
D-0680-2019
Dr. King's SafeCare Rx Lonely Mind & Body High Potency Homeopathic Formula for Professional Use Only, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside dr. Asheville, NC 28806 USA, UPC 357955200024, NDC 57955-2001-2
53 bottles
Microbial contamination
20180720
20190308
20220119
20190320
Lots: 010518H Exp. 01/20; 040616N Exp. 04/19
2026-05-14T17:41:53.783Z
null
drug/enforcement
Terminated
Little Rock
AR
United States
Class II
{}
Drugs
77780
Cantrell Drug Company
7321 Cantrell Rd
N/A
72207-4144
Voluntary: Firm initiated
Letter
Nationwide within the US
D-1074-2017
Phenylephrine HCL in 0.9% Sodium Chloride 10 mL, 1 mg/10 mL (100 mcg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222, NDC 52533-171-12
46078 syringes
Lack of Sterility Assurance.
20170714
20170809
20200916
20170816
Lot #: 9556, BUD: 7/26/2017; 9566, BUD: 7/30/2017; 9584, BUD; 8/1/2017; 9613, BUD: 8/6/2017; 9656, BUD: 8/14/2017; 9798, BUD: 9/11/2017; 9812, BUD: 8/31/2017; 9819, BUD: 9/16/2017; 9836, BUD: 9/17/2017; 9944, BUD: 10/3/2017; 10158, 10493, 10565, BUD: 10/30/2017
2026-05-14T17:41:53.806Z
null
drug/enforcement
Terminated
Lynwood
CA
United States
Class III
{}
Drugs
68003
Aaron Industries Inc
11865 Alameda St
90262-4022
Voluntary: Firm initiated
Telephone
Nationwide
D-1286-2014
Maximum Strength/Non-Drowsy Tussin DM Adult Maximum Strength, Cough Cold, Dextromethorphan HBr, USP, 10 mg (Cough Suppressant) , Guaifenesin, USP, 200 mg (Expectorant), 4, 8 fl oz bottles , OTC only, labeled as A) CareOne 8 fl oz bottle, Distributed by American Sales Company, Lancaster, NY 14086, UPC 341520339677, B) ...
108,792 bottles
Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles.
20140411
20140429
20150213
20140507
Lot #: 73762, 80030, 82053, 83032, 73768, 76414, 78222, 78441, 140423, 140494, 142396,145460,145959, 73831, 73832, 78440, 79819, 82606, 80969, 140530, 142413, 145461, 74163; Exp 06/14 Lot #:148820, 149396, 149995, 150208, 150422, 150599, 151023, 151071,151337, 148931,151072. ; Exp 08/15
2026-05-14T17:41:53.828Z
drug/enforcement
Terminated
San Francisco
CA
United States
Class II
{}
Drugs
73662
Reliable Rexall-A Compounding Pharmacy
801 Irving St
N/A
94122-2310
Voluntary: Firm initiated
Press Release
U.S. Including: CA, HI, NM
D-1135-2016
All potassium bromide Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.
N/A
Lack of Processing Controls
20160325
20160706
20170410
20160713
All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.
2026-05-14T17:41:53.850Z
null

FDA Data Scraper

Scrape FDA drug, device and food data from the official openFDA API β€” no login, no API key, no blocking. Drug recalls, adverse events (20M+), drug labels, device recalls and 510(k) clearances. Filter by firm, classification and date. Tens of thousands of records per run.

What the actor scrapes

πŸ’Š FDA Data Scraper β€” Drug & Device Recalls, Adverse Events & Labels via openFDA API Scrape FDA drug, device and food data straight from the official openFDA API β€” drug recalls, drug adverse events (20M+ records), drug labels, device recalls, device adverse events (24M+ records), 510(k) clearances and food recalls. This FDA data scraper needs no login and no API key, and one run can return tens of thousands of structured records ready to export to JSON, C

Who this is for

This sample is useful for anyone working in gov data, automation, developer tools who wants a quick look at the shape of the data before running the live actor at scale. Treat it as a static snapshot β€” counts, prices and timestamps reflect the moment the sample was captured and will drift over time.

Source

Live source: This dataset is a static sample. For fresh, customizable extractions, run the live Apify actor: logiover/fda-data-scraper

Fields

  • _dataset β€” field captured by the actor
  • status β€” field captured by the actor
  • city β€” city name
  • state β€” field captured by the actor
  • country β€” country name or code
  • classification β€” field captured by the actor
  • openfda β€” field captured by the actor
  • product_type β€” field captured by the actor
  • event_id β€” identifier
  • recalling_firm β€” field captured by the actor
  • address_1 β€” field captured by the actor
  • address_2 β€” field captured by the actor
  • postal_code β€” field captured by the actor
  • voluntary_mandated β€” field captured by the actor
  • initial_firm_notification β€” field captured by the actor
  • distribution_pattern β€” field captured by the actor
  • recall_number β€” field captured by the actor
  • product_description β€” field captured by the actor
  • product_quantity β€” field captured by the actor
  • reason_for_recall β€” field captured by the actor
  • recall_initiation_date β€” timestamp
  • center_classification_date β€” timestamp
  • termination_date β€” timestamp
  • report_date β€” timestamp
  • code_info β€” field captured by the actor
  • scrapedAt β€” timestamp the row was scraped

Sample preview

[
  {
    "_dataset": "drug/enforcement",
    "status": "Terminated",
    "city": "Peoria",
    "state": "IL",
    "country": "United States",
    "classification": "Class II",
    "openfda": {},
    "product_type": "Drugs",
    "event_id": "72241",
    "recalling_firm": "Kalman Health & Wellness, Inc. dba Essential Wellness Pharma",
    "address_1": "4625 N University St",
    "address_2": "N/A",
    "postal_code": "61614-5828",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "initial_firm_notification": "Letter",
    "distribution_pattern": "Nationwide",
    "recall_number": "D-321-2016",
    "product_description": "Progesterone 100 mg/mL in Corn Oil Injection, 2 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.",
    "product_quantity": "1 vial",
    "reason_for_recall": "Lack of Assurance of Sterility:  A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs.",
    "recall_initiation_date": "20150903",
    "center_classification_date": "20151117",
    "termination_date": "20171229",
    "report_date": "20151125",
    "code_info": "Lot #: 072915, Exp 10/29/2015",
    "scrapedAt": "2026-05-14T17:41:49.939Z"
  },
  {
    "_dataset": "drug/enforcement",
    "status": "Ongoing",
    "city": "San Juan Del Rio",
    "state": "N/A",
    "country": "Mexico",
    "classification": "Class II",
    "openfda": {},
    "product_type": "Drugs",
    "event_id": "86162",
    "recalling_firm": "Albek De Mexico S.A. De C.V.",
    "address_1": "Oriente Cuatro No. 11 Nuevo",
    "address_2": "N/A",
    "postal_code": "N/A",
    "voluntary_mandated": "Voluntary: Firm initiated",
    "initial_firm_notification": "Press Release",
    "distribution_pattern": "USA Nationwide",
    "recall_number": "D-0080-2021",
    "product_description": "Assured Instant Hand Sanitizer Aloe & Moisturizers (Ethyl Alcohol 70% v/v) 8 fl oz / 237 mL bottle, Distributed By: Greenbrier International, Inc. 500 Volvo Parkway, Chesapeake, VA 23320. Made in Mexico.UPC 639277928610",
    "product_quantity": "27,000 bottles",
    "reason_for_recall": "CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.",
    "recall_initiation_date": "20200730",
    "center_classification_date": "20201117",
    "report_date": "20201125",
    "code_info": "1931102AL",
    "scrapedAt": "2026-05-14T17:41:50.012Z"
  }
]

Snapshot stats

  • Row count in this sample: 100
  • Data quality flag at capture time: EXISTING_USED

License & Attribution

Released under Creative Commons Attribution 4.0 (CC BY 4.0). If you use this data, please credit the source actor and link back to its Apify Store page: logiover/fda-data-scraper.

The sample is provided as-is for evaluation and research. Source websites retain their own terms of service β€” downstream users are responsible for complying with them when running the live actor or redistributing scraped content.

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