[ 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.
839 matching recalls
| Date | Class | Firm | Reason | Quality domain |
|---|---|---|---|---|
| 2025-11-05 | Class III | Letco Medical LLCD-0138-2026 | Labeling: Not Elsewhere Classified | Documentation & Change Control |
| 2025-11-05 | Class II | QuVa Pharma, Inc.D-0113-2026 | Presence of Particulate Matter | Environmental Monitoring |
| 2025-11-05 | Class II | Amerisource Health Services LLCD-0101-2026 | Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit | Validation & Qualification |
| 2025-11-05 | Class II | SUN PHARMACEUTICAL INDUSTRIES INCD-0150-2026 | Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules. | Validation & Qualification |
| 2025-11-05 | Class II | Teva Pharmaceuticals USA, IncD-0106-2026 | CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit for the above specified lots. | Validation & Qualification |
| 2025-11-05 | Class II | Teva Pharmaceuticals USA, IncD-0105-2026 | CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit for the above specified lots. | Validation & Qualification |
| 2025-11-05 | Class II | ProRx LLCD-0116-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2025-11-05 | Class II | FARMAKEIO OUTSOURCING LLCD-0131-2026 | CGMP Deviations: Potential presence of metal particulate matter | Environmental Monitoring |
| 2025-11-05 | Class II | ProRx LLCD-0118-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2025-11-05 | Class II | FARMAKEIO OUTSOURCING LLCD-0124-2026 | CGMP Deviations: Potential presence of metal particulate matter | Environmental Monitoring |
| 2025-11-05 | Class II | ProRx LLCD-0115-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2025-11-05 | Class II | Amerisource Health Services LLCD-0102-2026 | Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit | Validation & Qualification |
| 2025-11-05 | Class II | Heritage Pharmaceuticals IncD-0108-2026 | CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level. | Validation & Qualification |
| 2025-11-05 | Class III | Endo USA, Inc.D-0142-2026 | Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C. | Validation & Qualification |
| 2025-11-05 | Class II | Samsung Bioepis Co., Ltd.D-0099-2026 | Lack of Assurance of Sterility. | Environmental Monitoring |
| 2025-11-05 | Class II | SUN PHARMACEUTICAL INDUSTRIES INCD-0144-2026 | Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules. | Validation & Qualification |
| 2025-11-05 | Class II | ProRx LLCD-0120-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2025-11-05 | Class II | FARMAKEIO OUTSOURCING LLCD-0136-2026 | CGMP Deviations: Potential presence of metal particulate matter | Environmental Monitoring |
| 2025-11-05 | Class II | Heritage Pharmaceuticals IncD-0112-2026 | CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level. | Validation & Qualification |
| 2025-11-05 | Class II | Kenvue Brands LLCD-0121-2026 | Defective Container | — |
| 2025-11-05 | Class II | SUN PHARMACEUTICAL INDUSTRIES INCD-0148-2026 | Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules. | Validation & Qualification |
| 2025-11-05 | Class II | FARMAKEIO OUTSOURCING LLCD-0132-2026 | CGMP Deviations: Potential presence of metal particulate matter | Environmental Monitoring |
| 2025-11-05 | Class II | ProRx LLCD-0119-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2025-11-05 | Class II | Otsuka ICU Medical LLCD-0143-2026 | Lack of Assurance of Sterility: Potential for flexible container leaks. | Environmental Monitoring |
| 2025-11-05 | Class II | FARMAKEIO OUTSOURCING LLCD-0123-2026 | CGMP Deviations: Potential presence of metal particulate matter | Environmental Monitoring |
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.