Datasets:
license: cc-by-4.0
task_categories:
- tabular-classification
tags:
- fda
- pharmaceutical
- recalls
- medical-devices
- drug-safety
- compliance
- regulatory
pretty_name: FDA Recall Intelligence
size_categories:
- 10K<n<100K
FDA Recall Intelligence
74,000+ FDA drug and device recalls enriched with facility inspection history, compliance action context, and AI-classified failure categories. Answers the question: what led to this recall, and what's the facility's track record?
Why This Dataset Exists
FDA publishes recall data separately from inspection and enforcement data. To understand why a recall happened and whether the facility has a pattern of problems, analysts must manually cross-reference 3–4 databases. This dataset pre-joins that context into a single row per recall.
Schema
| Column | Type | Description |
|---|---|---|
recall_number |
str | FDA recall identifier |
recall_type |
str | "drug" or "device" |
firm_name |
str | Recalling firm |
product_description |
str | Product being recalled |
reason_for_recall |
str | FDA-stated reason (free text) |
status |
str | Ongoing, Completed, Terminated |
recall_class |
str | Class I / II / III (device recalls) |
initiation_date |
date | When the recall was initiated |
report_date |
date | When FDA was notified |
distribution_pattern |
str | Geographic distribution of recalled product |
product_quantity |
str | Amount of product recalled |
product_ndc |
str | National Drug Code (drug recalls) |
fei_number |
str | Matched FDA Establishment Identifier |
facility_total_inspections |
int | Inspection count for this facility |
facility_oai_count |
int | Serious inspection failures at this facility |
facility_last_classification |
str | Most recent inspection outcome |
facility_last_inspection |
date | When facility was last inspected |
facility_compliance_actions |
int | Warning Letters / Injunctions / Seizures |
facility_warning_letters |
int | Warning Letters issued to this facility |
preceded_by_oai |
bool | Was the most recent inspection before this recall an OAI? |
days_since_last_inspection |
int | Days between last inspection and recall initiation |
Key Insights
- 74,000+ total recalls (23,000+ drug, 50,000+ device)
- 79% matched to an FDA-inspected facility
- 4,100+ recalls preceded by an OAI inspection
- Date range: 2005 – present
AI-Enriched Failure Categories (Drug Recalls)
17,000+ drug recalls have been classified by failure mode using Claude AI:
| Category | Count | Share |
|---|---|---|
| Sterility | 6,469 | 37% |
| cGMP Deviations | 3,536 | 20% |
| Contamination | 1,922 | 11% |
| Potency | 1,573 | 9% |
| Mislabeling | 1,416 | 8% |
| Stability | 890 | 5% |
| Foreign Material | 694 | 4% |
Each classification includes a subcategory (e.g., "penicillin cross-contamination", "subpotent API", "label mixup") for granular analysis. Device recall classifications are in progress.
Sample
This is a 10% random sample. The full dataset is available for purchase — details below.
Sources
- OpenFDA Drug Enforcement (drug recalls)
- OpenFDA Device Enforcement (device recalls)
- DDAPI Inspections & Classifications (facility context)
- DDAPI Compliance Actions (enforcement context)
License
Derived from U.S. government public data. AI classifications generated by Claude (Anthropic). Provided as-is.
Purchase
For the full dataset: https://mandiasdata.gumroad.com/l/fda-recall-intelligence