[ 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 |
|---|---|---|---|---|
| 2025-09-24 | Class II | Amerisource Health Services LLCD-0648-2025 | Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any tablets. | Documentation & Change Control |
| 2025-09-24 | Class II | Amerisource Health Services LLCD-0649-2025 | Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any tablets. | Documentation & Change Control |
| 2025-09-24 | Class II | Amerisource Health Services LLCD-0647-2025 | Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any tablets. | Documentation & Change Control |
| 2025-09-24 | Class II | Sandoz IncD-0651-2025 | cGMP deviations: Temperature excursion during transportation. | Risk Management & CAPA |
| 2025-09-24 | Class II | Amerisource Health Services LLCD-0650-2025 | Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any tablets. | Documentation & Change Control |
| 2025-09-24 | Class II | SUN PHARMACEUTICAL INDUSTRIES INCD-0658-2025 | Failed Dissolution Specifications-Out of Specification (OOS) observation for sulphate in Sodium Tartrate Dihydrate used for the production of Mertiatide. | Validation & Qualification |
| 2025-09-24 | Class II | Ascend Laboratories, LLCD-0645-2025 | Superpotent drug | Validation & Qualification |
| 2025-09-24 | Class I | Unichem Pharmaceuticals USA Inc.D-0655-2025 | Labeling: Label Mix Up; Bottles of Meloxicam USP, 7.5mg, 90-count tablets (yellow in color), were labeled as Cyclobenzaprine Hydrochloride Tablets USP, 10 mg 90-count tablets (blue in color). | Documentation & Change Control |
| 2025-09-24 | Class II | Northwind Pharmaceuticals LLCD-0654-2025 | Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) was detected with presence of a micro-organism. No micro-organism was detected on any tablets. | Documentation & Change Control |
| 2025-09-17 | Class II | Breckenridge Pharmaceutical, Inc.D-0621-2025 | CGMP deviations: N-nitroso-duloxetine impurity above the proposed interim limit. | Validation & Qualification |
| 2025-09-17 | Class II | Zydus Pharmaceuticals (USA) IncD-0623-2025 | Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation impurity. | Validation & Qualification |
| 2025-09-17 | Class II | Zydus Pharmaceuticals (USA) IncD-0639-2025 | 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 | Zydus Pharmaceuticals (USA) IncD-0634-2025 | 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-0630-2025 | CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit | Risk Management & CAPA |
| 2025-09-17 | Class II | Lannett Company Inc.D-0642-2025 | Presence of Foreign Tablet/Capsule: Two (2) bottles labeled as Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 10mg, 100ct, contained one (1) tablet of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, 5 mg. | Documentation & Change Control |
| 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 | Exela Pharma Sciences LLCD-0620-2025 | Failed Impurities/Degradation Specifications: out of specification results for arsenic in the impurities tested. | Validation & Qualification |
| 2025-09-17 | Class II | World Perfumes Inc.D-0622-2025 | Defective Container: broken or leaking bottles. | — |
| 2025-09-17 | Class II | Zydus Pharmaceuticals (USA) IncD-0638-2025 | CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit | Risk Management & CAPA |
| 2025-09-17 | Class II | AvKARED-0643-2025 | Presence of a foreign substance. | — |
| 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 | The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby LaboratoriesD-0625-2025 | Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) was detected with presence of a micro-organism. No micro-organism was detected on any tablets. | Documentation & Change Control |
| 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 | AvKARED-0644-2025 | Presence of a foreign substance. | — |
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.