[ 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.
409 matching recalls
| Date | Class | Firm | Reason | Quality domain |
|---|---|---|---|---|
| 2025-09-17 | Class II | Zydus Pharmaceuticals (USA) IncD-0633-2025 | CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit | Risk Management & CAPA |
| 2025-09-17 | Class II | Zydus Pharmaceuticals (USA) IncD-0636-2025 | CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit | Risk Management & CAPA |
| 2025-09-17 | Class II | Zydus Pharmaceuticals (USA) IncD-0635-2025 | CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit | Risk Management & CAPA |
| 2025-09-17 | Class II | Zydus Pharmaceuticals (USA) IncD-0631-2025 | CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit | Risk Management & CAPA |
| 2025-09-17 | Class II | Zydus Pharmaceuticals (USA) IncD-0632-2025 | CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit | Risk Management & CAPA |
| 2025-09-17 | Class II | Atlantic Management Resources Ltd.D-0629-2025 | cGMP violations | Risk Management & CAPA |
| 2025-09-17 | Class II | Zydus Pharmaceuticals (USA) IncD-0630-2025 | CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit | Risk Management & CAPA |
| 2025-09-03 | Class II | Amerisource Health Services LLCD-0598-2025 | 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 |
| 2025-08-20 | Class II | AND GO CONCEPTS DBA SALAD AND GOH-0493-2025 | The firm manufactured and distributed to retailers unpasteurized juice products in violation of 21 CFR 120 Juice HACCP regulations | Risk Management & CAPA |
| 2025-08-20 | Class II | AND GO CONCEPTS DBA SALAD AND GOH-0492-2025 | The firm manufactured and distributed to retailers unpasteurized juice products in violation of 21 CFR 120 Juice HACCP regulations | Risk Management & CAPA |
| 2025-08-20 | Class II | Westminster Pharmaceuticals LLCD-0581-2025 | CGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable Daily Intake (ADI) level. | Risk Management & CAPA |
| 2025-08-20 | Class II | AND GO CONCEPTS DBA SALAD AND GOH-0494-2025 | The firm manufactured and distributed to retailers unpasteurized juice products in violation of 21 CFR 120 Juice HACCP regulations | Risk Management & CAPA |
| 2025-08-20 | Class II | Westminster Pharmaceuticals LLCD-0582-2025 | CGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable Daily Intake (ADI) level. | Risk Management & CAPA |
| 2025-08-13 | Class II | AEQUITA PHARMACYD-0556-2025 | Lack of Processing Controls. | Risk Management & CAPA |
| 2025-08-13 | Class II | AEQUITA PHARMACYD-0560-2025 | Lack of Processing Controls. | Risk Management & CAPA |
| 2025-08-13 | Class II | AEQUITA PHARMACYD-0561-2025 | Lack of Processing Controls. | Risk Management & CAPA |
| 2025-08-13 | Class II | AEQUITA PHARMACYD-0565-2025 | Lack of Processing Controls. | Risk Management & CAPA |
| 2025-08-13 | Class II | AEQUITA PHARMACYD-0557-2025 | Lack of Processing Controls. | Risk Management & CAPA |
| 2025-08-13 | Class II | AEQUITA PHARMACYD-0564-2025 | Lack of Processing Controls. | Risk Management & CAPA |
| 2025-08-13 | Class II | AEQUITA PHARMACYD-0559-2025 | Lack of Processing Controls. | Risk Management & CAPA |
| 2025-08-13 | Class II | AEQUITA PHARMACYD-0563-2025 | Lack of Processing Controls. | Risk Management & CAPA |
| 2025-08-13 | Class II | AEQUITA PHARMACYD-0553-2025 | Lack of Processing Controls. | Risk Management & CAPA |
| 2025-08-13 | Class II | AEQUITA PHARMACYD-0555-2025 | Lack of Processing Controls. | Risk Management & CAPA |
| 2025-08-13 | Class II | AEQUITA PHARMACYD-0562-2025 | Lack of Processing Controls. | Risk Management & CAPA |
| 2025-08-13 | Class II | AEQUITA PHARMACYD-0554-2025 | Lack of Processing Controls. | Risk Management & CAPA |
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.