Datasets:

AfiadataKe
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ppb-kenya-recalls-dataset

year int64 2.02k 2.03k	date stringdate 18-03-13 00:00:00 2025-12-29 00:00:00	recall_ref stringlengths 12 12 ⌀	product_name stringlengths 3 70	inn_name stringlengths 7 201	batch_no stringlengths 3 199	manufacturer stringlengths 3 70 ⌀	reason stringlengths 12 250
2,016	11/12/2013	null	Biomol tablets	Paracetamol	All batches	Biodeal Laboratories Ltd	Color change and moulding
2,016	24/09/2015	null	Beta gripe water	Gripe water	11A, 2A, 6A, 7A, 11A	Beta Healthcare International	the batches had problems of floculation
2,016	15/06/2016	null	OPVERO	Oral Polio Vaccine	M5169-1	Sanofi Aventis	To replace trivalent with bivalent OPV
2,017	29/03/2017	null	Clopidogrel with Aspirin	Clopidogrel and Aspirin	E31614002	Unicure Remedies	The product failed dissolution test, assay test and weight variation
2,017	05/04/2017	null	Dulcolax 5mg	Bisacodyl	160697	Boehringer	Detected Out of specification for dissolution test
2,017	12/05/2017	null	Asmol 500mg	Paracetamol	2769 and 2019	Astra Lifecare Ltd	Moulding of tablets
2,017	12/11/2017	null	Glucose 5D	Dextrose	1015461	Shree Krishna Keshav Lab Ltd	Particulate matter
2,017	13/11/2017	null	Claxy 228.5mg	Amoxicillin and Clavulanic acid	EBD170033	Theon Pharmaceuticals ltd	Color change
2,017	13/11/2017	null	Rhoclone 300mcg	Anti Rho-D Immunoglobulin	Missing	Bharat Serums and Vaccines Ltd	Product lacks proper labelling, batch number, DOM, DOE
2,017	13/11/2017	null	Festate tablet	Ferrous Sulphate	WG14295	Westcoast Pharmaceutical works	Color change and appearance of dark spots on tablets
2,017	16/11/2017	null	Upacof Syrup	Diphenhydramine and Promethazine	510235 and 610120	Universal Corporation Ltd	The product has an OOS result for Promethazine content
2,017	20/11/2017	null	Erocin Powder for reconstitution	Erythromycin	67473, 64685	Laboratory and Allied Ltd	Unpleasant taste and odor, lumping
2,017	23/11/2017	null	Dinac gel	Diclofenac	All batches	Universal Corporation Ltd	The product failed to comply with assay, description, and related substances
2,017	07/12/2017	null	Methomine S	Sulfadoxine and Pyrimethamine	421214	Universal Corporation Ltd	Color change
2,018	13/03/18	null	Altacef Suspension	Cefuroxime	320416047, 320416050, 320616051, 320416060, 7320001, 7320002	Glenmark Pharmaceuticals	Voluntary recall
2,018	04/04/18	null	Metrowin 200	Metronidazole	150810	Shandong Xier Kangtai	Color change
2,018	07/04/18	null	Ventil 4mg	Salbutamol	815109	Biodeal Laboratories Ltd	The product is reported to have inconsistent colouration and dark brown spots
2,018	12/04/18	null	Moods Ultrathin Condoms	Condoms	L45UT009	HLL Lifecare Ltd	The batch failed Freedom from holes test
2,018	25/06/18	null	Zeosorb	Food supplement	All batches	Bayer AG Leverkusen	Voluntary withdrawall
2,018	06/08/18	null	Safil and Novosyne sutures	Sutures	717394, 717432, 717436, 718035	B. Braun Surgical S.A	Voluntary recall
2,018	20/09/2018	null	Fiesta Stamina	Condoms	DL1608	Cupid Ltd	batch failed freedom from holes test
2,018	20/09/2018	null	Fiesta Big Black	Condoms	PL1625	Cupid Ltd	batch failed thickness test
2,018	17/10/2018	null	Fluphenazine Decanoate injection	Fluphenazine	70327	Rotexmedica Germany	Voluntary recall due to OOS for the assay test
2,018	15/11/2018	null	Zenagent	Gentamicin	IZGIE001,IZGIE002, IZGIE003, IZGIE004	Laborate Pharmaceuticals	Adverse Event following adminstartion
2,018	20/11/2018	null	Elymox 125mg/5ml	Amoxicillin	8-E62	Elys Chemical Industries Ltd	the batch failed Assay test
2,018	20/11/2018	null	Labmox 125 Oral suspension	Amoxicillin	ILBDE-003	Laborate Pharmaceuticals	The batch failed Assay test
2,018	20/11/2018	null	Strox 500mg	Ciprofloxacin	5802163	Universal Corporation Ltd	The batch failed dissolution test
2,018	20/11/2018	null	Rough rider studded	Condoms	1509031616	Ansell Healthcare	The batch failed width test
2,018	20/11/2018	null	Acepril 5mg	Enalapril	70439, 72061	Laboratory and Allied Ltd	the batches failed Dissolution test
2,018	20/11/2018	null	Parol Oral Suspension	Paracetamol	180277	Atabay Ilac	the batch failed Assay test
2,018	26/11/2018	null	Wombit tablet	Albendazole	0218071, 0218072, 0317120, 0717071	Biodeal Laboratories Ltd	Failed dissolution testing
2,018	28/11/2018	null	Almex tablets	Albendazole	8AO2938	Square Pharmaceuticals	The batch failed dissolution test
2,019	02/01/2019	null	Fiesta stamina	Condoms	DL1608	DKT	Failed freedom from holes test
2,019	02/01/2019	null	Fiesta Big Black	Condoms	PL1625	DKT	Failed thickness test
2,019	18/01/2019	null	Jotonol 500mg	Paracetamol	T00418	Benmed Pharmaceuticals	The batch failed dissolution test
2,019	18/01/2019	null	Zegra 50mg	Sildenafil	00-218	Benmed Pharmaceuticals	The batch failed assay test, dissolution test and uniformity of weight
2,019	15/02/2019	null	Cipcina tablet	Ciprofloxacin	170520	Shanxi Xinyitong Pharmaceutical Co. Ltd	Failed assay test
2,019	18/02/2019	null	ABZ tablet	Albendazole	ABX1B83	Indoco remedies	the batches failed Dissolution test
2,019	25/02/2019	null	Trogyl tablets	Metronidazole	0418033, 0418034	Biodeal Laboratories Ltd	Black spots on the tablets
2,019	25/02/2019	null	Silvadine cream 1%	Silver Sulfadiazine	0618003, 1118099	Biodeal Laboratories Ltd	Voluntary recall following a PPB notification of market complaint on PQMP
2,019	24/04/2019	null	Levonogets 0.75mg	Levonogestrel	P17G003	Olive Healthcare, India	The batch failed dissolution test, weight variation and Assay
2,019	09/05/2019	null	Sure lubricated condoms dotted	Condoms	P48045, L48037, P48001,P48001, P48027	HLL Lifecare,	Out of specification for freedom from holes and quantity of lubricant
2,019	09/05/2019	null	Sure lubricated condoms dotted	Condoms	17DN754, 17DN052	Innolatex Thailand Ltd	Out of specification for freedom from holes and quantity of lubricant
2,019	18/06/2019	null	Toramin syrup	Chlorpheniramine	180626	Comet Healthcare	Color change
2,019	03/07/2019	null	Wombit tablet	Albendazole	0218071, 0218072, 0317120, 0717073	Biodeal Laboratories Ltd	Failed dissolution testing
2,019	28/08/2019	null	Atazor-R	Atazanavir/Ritonavir 300/100MG	EM83045, EM803076	Emcure Pharmaceuticals Ltd	due to an Out of trend result for Hydroxy ritonavir impurity at 12 month stability time point
2,019	19/09/2019	null	Atazor-R	Atazanavir/Ritonavir 300/100MG	All batches	Emcure Pharmaceuticals Ltd	Product was out of trend at 12 months when stored at 30/75% RH
2,019	19/09/2019	null	Atazor-R	Atazanavir/Ritonavir 300/100MG	EM83045	Emcure Pharmaceuticals Ltd	Product was Out of trend results at 12 months when stored at 30/75% RH. Recall was specific to 500,000 pack of 30s supplied to NASCOP through KEMSA
2,019	01/10/2019	null	Kemoxyl DT 250mg	Amoxicillin	69660	Laboratory and Allied Ltd	The batch failed dissolution test
2,019	10/11/2019	null	Silvamax cream	Chlorhexidine,silver sulfadiazine	5804914	Universal Corporation Ltd	The batch reported stability falure for CHX content
2,019	20/11/2019	null	Alben oral suspension	Albendazole	54517008	GSK	The batch failed Assay test
2,020	12/03/20	null	Unibrol 250mg tablets	Aminosidine	5806898, 5806675	Universal Corporation Ltd	Change in tablet appearance and incomplete pack
2,020	14/04/20	null	Kenazole cream	Ketoconazole	1907205	Dawa Ltd	Incomplete pack
2,020	01/05/20	null	Dolac 30	Ketorolac	Y48E8001	Cadilla Pharmaceuticals	Voluntary recall due to Incorrect labeling
2,020	15/05/20	null	Ascorbic acid	Vitamin C	1909306, 1907166, 1812006	Dawa Ltd	Color change, recalled by rwandan FDA
2,020	10/06/20	null	Asmol tablet	Paracetamol	2282, 2284	Opera Pharmaceuticals-LTR	Tablets are reported as molding and turning black
2,020	17/06/20	null	8-0 Blue twisted silk suture	Sutures	Assorted	Johnson and Johnson	Voluntary recall
2,020	24/06/2020	null	Microplas plasmafilter	Plasmafilter	IBP4102,IBP4103, IBP4104	Bellco	A Plasma filter is used instead of a hemofilter
2,020	10/07/2020	null	Deep heat patch	Mentholatum	201903B0, 202001C0	The metholatum company UK	Therapeutic ineffectiveness
2,020	14/09/20	null	Allucid Plus	Aluminium hydroxide, Magnesium hydroxide and Simethicone	1019101, 1019093	Biodeal Laboratories Ltd	Voluntary recall following visible particles reports
2,020	02/10/2020	null	Triohist syrup	Chlorpheniramine, diphenhydramine, promethazine, ephedrine, ammonium chloride, sodium citrate, and menthol	71550	Laboratory and Allied Ltd	Color change
2,020	19/10/2020	null	Magnocid Mixture	Magnesium carbonate, Sodium carbonate	0720141 and 0720142	Biodeal Laboratories Ltd	Voluntary recall following color change
2,020	23/10/2020	null	Dawasprin 300	Aspirin	1906109.1906108, 1907040, 1907042, 1907041, 1906106, 1907217	Dawa Ltd	broken tablets
2,020	19/11/2020	null	Dawapraz 20	Omeprazole	1811147	Dawa Ltd	The product failed dissolution test
2,020	24/11/2020	null	Atracurium	Atracurium	AB11927BC, AB11914BC, AB11705BC	Celon laboratories Ltd	Therapeutic ineffectiveness
2,020	24/11/2020	null	Lamprene 100mg	Clofazimine	JM4107 and JB9534	Norvatis	Clamping and lose of coat color
2,020	24/11/2020	null	Warfarin 5mg	Warfarin	All batches	Njimia Pharmaceuticals	Color change and hard to break
2,020	16/12/2020	null	Rinacet 10mg	Cetrizine	2006164	Dawa Ltd	Voluntary recall due to failure to meet labeling requirements
2,021	10/05/2021	null	Losar-Denk,	Lorsatan	All batches	Denk Pharma	Discovery of 4-chlor-azidomethyltetrazole
2,021	10/05/2021	null	Co-losar Denk	losartan and Hydrochlorthiazide	All batches	Denk Pharma	Discovery of 4-chlor-azidomethyltetrazole
2,021	10/07/2021	null	Tanzol 400mg	Albendazole	371166	Shalina Healthcare	The product failed dissolution test
2,021	26/07/2021	null	Dazole 1%	Clotrimazole	1808208, 1901255, 1904237, 1904247, 1906123	Dawa Ltd	Leaking contents
2,021	06/08/2021	null	Totomol suspension	Paracetamol	78587	Laboratory and Allied Ltd	Voluntary recall following crystallization
2,021	25/08/2021	null	Carbocysten-promethazine syrup	Carbocystein and promethazine	Several batches	Dawa Ltd	Voluntary recall due to fail of assay of FUST
2,021	31/08/2021	null	Frusemide 40mg	Frusemide	2105115, 2105116	Dawa Ltd	voluntary recall because of soft tablets
2,021	27/09/2021	null	Zolex 400	Albendazole	ZOL803	null	The product failed dissolution test
2,021	06/10/2021	null	Biotrim suspension	Trimethoprim suphamethoxazole	520094	Biodeal Laboratories Ltd	Color change
2,021	21/10/2021	null	Irbesatan finished products	Irbesartan	AA548, AA645, AA664, AA193, AA707, AMXA007, AMXA005, AMXA003, AMXA004, 9MXA005,	Sanofi Aventis	Potential presence of GTI2
2,022	14/12/2022	REC/2022/011	Famcal tablets	Calcium citrate maleate with Cholecalciferol	FDF1AD3B	Indoco Remedies Limited, India	Out of specification results on assay test identified during stability studies
2,022	13/12/2022	REC/2022/010	Umbicare gel	Chlorhexidine Gluconate Gel 7.1% w/w	UAM1IC1B	Indoco Remedies Limited, India	Out Of Specification results on related substances tests
2,022	07/12/2022	REC/2022/009	Tenofovir Disoproxil Fumarate/ Lamivudine/ Dolutegravir	Tenofovir Disoproxil Fumarate/ Lamivudine/ Dolutegravir 300/300/50mg	Several	Universal Corporation Limited, Kenya	Discoloration of induction seal, broken tablets and black spots on the tablets
2,022	12/09/2022	REC/2022/008	Biodine Mouth Gargle	Povidone Iodine	0122081, 0122082, 0322054, 0322055, 0322056, 0322057	Biodeal Laboratories Ltd, Kenya	Change of color to colorless
2,022	01/07/2022	REC/2022/007	Rocephin Ig Injection	Ceftriaxone 1g	B0752B04	F. Hoffmann-La Roche Ltd, Kaiseraugst	Detection of pinholes in 10 mL Water for Injection (WFI) ampoules
2,022	24/06/2022	REC/2022/006	EEATM Auto SutureTM Circular Stapler with DST SeriesTM Technology 25mm	Intraluminal circular stapler	All	Covidien llc 15 Hampshire Street Mansfield, USA	A complaint was reported as “Staples Did Not Deploy”. According to the reporter, during laparoscopic procedure the circular stapler was able to fire, but the staples did not deploy when attempting to staple a small bowel segment to the gastric pouch.
2,022	24/06/2022	REC/2022/005	Dawaflox DPS suspension 100ml	Flucloxacillin	2006121, 2012085	Dawa Lifesciences Ltd	Failure of assay identified during stability studies
2,022	06/04/2022	REC/2022/004	Biodopa tablets	Methyldopa 250mg	0321077, 0421112, 0421142	Biodeal Laboratories Ltd	Discoloration of the tablets
2,022	07/03/2022	REC/2022/003	Vasofix certo G24X19MM yellow	Peripheral vascular infusion catheter	20A19G8334, 20A21G8381	B.Braun Melsungen AG	A defect on the injection port that may result in potentially critical clinical consequences for the patient e.g blood loss, underdosage or delay of therapy. Third party are at risk being inContact with patients fluids.
2,022	21/02/2022	REC/2022/002	Alkar-UR effervescent granule satchets	Sodium Bicarbonate 1.76g, Tartaric Acid 0.890 g, Citric acid anhydrous 0.720g, Trisodium citrate anhydrous 0.630 gm	3620100	National Pharmaceutical Industries Co (SAOG) Muscat, Sultanate of Oman	Sachets bloated and powder agglomerated
2,022	14/01/2022	REC/2022/001	Pregsmile tablets	Doxylamine/ Pyridoxine/Folic acid	EKE-235	Corona Remedies Pvt.Ltd, India	Mix up (found to contain blisters of Rosuvastatin)
2,023	07/12/2023	REC/2023/018	Nycodeal 30ml	Nystatin 100,000 IU/ML	0523083, 0523084	Biodeal Laboratories Ltd, Kenya	During routine market surveillance activities, an Out Of Specification (OOS) result of 81.7% was observed in the assay test, with the specified limits ranging from 95.0% to 120.0% of the stated amount.
2,023	15/11/2023	REC/2023/017	Lasideal Tablets	Furosemide	0621126	Biodeal Laboratories Ltd, Kenya	Black Spots on the tablets
2,023	15/11/2023	REC/2023/016	Enril 5	Enalapril Maleate	KN532	Prism Life Sciences LTD, India	Out Of Specification (OOS) results following routine market surveillance activities
2,023	17/10/2023	REC/2023/015	Beeclav 457mg Suspension	Amoxicillin & Clavulanic acid	SEBPD-0088	Prism Life Sciences LTD, India	Color change to brown after reconstitution
2,023	18/09/2023	REC/2023/014	Rapiclav 312.5 DT	Amoxicillin & Potassium Clavulanate	JTQ012001 JTQ012002 JTQ012003 JTQ012004 JTQ012005 JTQ012006 JTQ012007 JTQ012008 JTQ012009 JTQ012010 JTQ012011 JTQ012012 JTQ012013 JTQ012014 JTQ012015 JTQ012016 JTQ012017 JTQ012018 JTQ012019 JTQ012020	IPCA laboratories, India	Color change of tablets
2,023	18/09/2023	REC/2023/013	Oralex C Mouthwash	Chlorhexedine Gluconate & Benzydamine Hydrochloride	L220077	Curis Lifesciences PVT LTD, India	Out Of Specification (OOS) results following routine market surveillance activities
2,023	18/09/2023	REC/2023/012	Trimoxol	Cotrimoxazole	22100332205033, 2210005, 2201145, 2207184	Dawa life sciences, Kenya	Market Complaints of bitter taste
2,023	18/09/2023	REC/2023/011	Tamedol Suspension	Paracetamol 120mg/5ml	All Batches	Biopharma LTD, Kenya	Failure to meet prescribed market authorization requirements
2,023	21/08/2023	REC/2023/010	Klincord Solution	Chlorhexidine Digluconate 7.1% drops	WS21136	West Coast Pharmaceuticals, India	The assay of the active ingredient in the product may likely drop below the specifications of 95-105% based on stability data
2,023	17/08/2023	REC/2023/009	DTO	Ofloxacin/Ornidazole	DDBR2201	Coral Lab Ltd, India	Change in color
2,023	15/06/2023	REC/2023/008	Mesporin	Ceftriaxone 500mg, 1000mg, 2000mg	Z0142, Z0153 ,Z0030, Z0129 Z0086, Z0115, Z0149, Z0057, Z0107	Labestfal Almiro Laboratories S.A., Portugal	Visible particles in reconstituted powder of the product

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PPB Kenya Recalls

Structured data on medicine and medical device recalls and rapid alerts issued by the Pharmacy and Poisons Board (PPB) of Kenya, covering 2016 to 2025.

Load the dataset

from datasets import load_dataset

# Recall notices (default)
recalls = load_dataset("afiadata/ppb-kenya-recalls", "recalls")

# Rapid alerts
alerts = load_dataset("afiadata/ppb-kenya-recalls", "rapid_alerts")

Or with pandas directly:

import pandas as pd

recalls = pd.read_csv("https://huggingface.co/datasets/afiadata/ppb-kenya-recalls/resolve/main/recalls_combined.csv")
alerts  = pd.read_csv("https://huggingface.co/datasets/afiadata/ppb-kenya-recalls/resolve/main/rapid_alerts.csv")

Dataset structure

recalls (183 records, 2016–2025)

Column	Description
`year`	Year the recall was issued
`date`	Date of the recall notice
`recall_ref`	Official PPB reference number (`REC/YYYY/NNN`). Empty for pre-2022 records.
`product_name`	Brand name of the recalled product
`inn_name`	International Non-proprietary Name (generic name) and strength
`batch_no`	Affected batch number(s)
`manufacturer`	Manufacturer name and country
`reason`	Reason for recall as stated in the PPB notice

rapid_alerts (62 records, 2018–2025)

Column	Description
`year`	Year the alert was issued
`date`	Date of the alert
`title`	Full title of the alert
`pdf_url`	URL to the PDF on the PPB website, where available
`pdf_filename`	Corresponding local PDF filename, if available
`product_type`	Product category (Medicine, Medical device, Excipient)
`source`	Issuing body (PPB or WHO)
`manufacturer`	Stated or confirmed manufacturer

Additional files

The full dataset repository also includes:

recalls_full_text.jsonl — extracted text from recall PDFs (digital + OCR)
rapid_alerts_full_text.jsonl — extracted text from rapid alert PDFs
manifest_recalls.csv — PDF-to-record linkage for recalls
manifest_rapid_alerts.csv — PDF-to-record linkage for rapid alerts
curation_log.csv — documents manual corrections and records needing review
recall_pdfs/ — source PDF documents
rapid_alerts_pdfs/ — source PDF documents

See data_dictionary.md for full column definitions.

Source

All records originate from the PPB website (pharmacyboardkenya.org). Rapid alerts include both PPB-issued notices and WHO alerts circulated by PPB.

Citation

@dataset{afiadata_ppb_kenya_recalls_2026,
  author    = {Afiadata},
  title     = {PPB Kenya Recalls Dataset},
  year      = {2026},
  publisher = {Hugging Face},
  url       = {https://huggingface.co/datasets/afiadata/ppb-kenya-recalls}
}

License

CC BY 4.0 — free to use, share, and adapt with attribution.

Attribution: PPB Kenya Recalls Dataset, compiled by Afiadata. Original source: Pharmacy and Poisons Board of Kenya (pharmacyboardkenya.org).

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