[ 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 |
|---|---|---|---|---|
| 2025-11-12 | Class II | Zydus Pharmaceuticals (USA) IncD-0153-2026 | cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit. | Validation & Qualification |
| 2025-11-05 | Class II | SUN PHARMACEUTICAL INDUSTRIES INCD-0149-2026 | 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 III | Endo USA, Inc.D-0140-2026 | Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C. | Validation & Qualification |
| 2025-11-05 | Class II | FARMAKEIO OUTSOURCING LLCD-0133-2026 | CGMP Deviations: Potential presence of metal particulate matter | Environmental Monitoring |
| 2025-11-05 | Class II | Heritage Pharmaceuticals IncD-0107-2026 | CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level. | Validation & Qualification |
| 2025-11-05 | Class II | FARMAKEIO OUTSOURCING LLCD-0127-2026 | CGMP Deviations: Potential presence of metal particulate matter | Environmental Monitoring |
| 2025-11-05 | Class II | Heritage Pharmaceuticals IncD-0109-2026 | CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level. | Validation & Qualification |
| 2025-11-05 | Class II | Heritage Pharmaceuticals IncD-0111-2026 | CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level. | Validation & Qualification |
| 2025-11-05 | Class II | Teva Pharmaceuticals USA, IncD-0104-2026 | 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 | FARMAKEIO OUTSOURCING LLCD-0134-2026 | CGMP Deviations: Potential presence of metal particulate matter | Environmental Monitoring |
| 2025-11-05 | Class II | FARMAKEIO OUTSOURCING LLCD-0129-2026 | CGMP Deviations: Potential presence of metal particulate matter | Environmental Monitoring |
| 2025-11-05 | Class II | FARMAKEIO OUTSOURCING LLCD-0126-2026 | CGMP Deviations: Potential presence of metal particulate matter | Environmental Monitoring |
| 2025-11-05 | Class II | Heritage Pharmaceuticals IncD-0110-2026 | CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level. | Validation & Qualification |
| 2025-11-05 | Class II | SUN PHARMACEUTICAL INDUSTRIES INCD-0147-2026 | 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-0114-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2025-11-05 | Class II | ACME UNITED CORPORATIOND-0122-2026 | Product Mix-up | Documentation & Change Control |
| 2025-11-05 | Class II | SUN PHARMACEUTICAL INDUSTRIES INCD-0146-2026 | 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-0117-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2025-11-05 | Class II | FARMAKEIO OUTSOURCING LLCD-0125-2026 | CGMP Deviations: Potential presence of metal particulate matter | Environmental Monitoring |
| 2025-11-05 | Class III | Endo USA, Inc.D-0139-2026 | Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C. | Validation & Qualification |
| 2025-11-05 | Class III | Endo USA, Inc.D-0141-2026 | Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C. | Validation & Qualification |
| 2025-11-05 | Class II | Breckenridge Pharmaceutical, Inc.D-0100-2026 | CGMP Deviations: N-nitroso-duloxetine impurity above the safety assessment limit of 12.5ppm. | Validation & Qualification |
| 2025-11-05 | Class II | FARMAKEIO OUTSOURCING LLCD-0135-2026 | CGMP Deviations: Potential presence of metal particulate matter | Environmental Monitoring |
| 2025-11-05 | Class II | SUN PHARMACEUTICAL INDUSTRIES INCD-0145-2026 | 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-0130-2026 | 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.