[ FDA ENFORCEMENT INTELLIGENCE ]
Learn from the record. Every FDA recall is a quality signal.
Live drug, device & food recall data from the FDA (openFDA enforcement) — food spanning dietary supplements, cosmetics & animal food — mapped to the GxP quality domains SPEQ assesses, so you can see where control breaks down across every regulated industry.
1,000
Total recalls
217
Class I (most serious)
167
Drug
515
Device
318
Food / supplement / cosmetic
Last 12 months · latest report 2026-07-22 · source: openFDA enforcement
RECALLS BY CLASSIFICATION · MONTHLY
RECALL REASONS BY QUALITY DOMAIN
Domain mapping is a SPEQ interpretation of the FDA recall reason, not an official FDA classification.
832 matching recalls
| Date | Class | Firm | Reason | Quality domain |
|---|---|---|---|---|
| 2025-08-06 | Class II | Pfizer Inc.D-0544-2025 | CGMP Deviations; particulates identified during visual inspection | Environmental Monitoring |
| 2025-08-06 | Class II | Nostrum Laboratories, Inc.D-0547-2025 | CGMP Deviations: The recalling firm filed for Chapter 11 in September 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated. | Risk Management & CAPA |
| 2025-08-06 | Class II | FDC LimitedD-0543-2025 | Defective Container: spike of the cap becomes lodged in the nozzle of the product bottle. | — |
| 2025-08-06 | Class II | Lupin Pharmaceuticals Inc.D-0542-2025 | Labeling: Incorrect or Missing Lot and/or Exp Date: released with wrong expiry date as Feb.2027 instead of Jan.2027 | Validation & Qualification |
| 2025-08-06 | Class II | Pfizer Inc.D-0545-2025 | CGMP Deviations; particulates identified during visual inspection | Environmental Monitoring |
| 2025-08-06 | Class II | Strides Pharma, Inc.D-0546-2025 | Failed Dissolution Specifications. | Validation & Qualification |
| 2025-08-06 | Class II | Hikma Pharmaceuticals USA Inc.D-0551-2025 | Failed Impurities/Degradation Specifications: An out-of-Specification for total related compounds | Validation & Qualification |
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Data: U.S. FDA openFDA enforcement API. Quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Recall details are as reported by the FDA.