[ 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.
315 matching recalls
| Date | Class | Firm | Reason | Quality domain |
|---|---|---|---|---|
| 2025-12-17 | Class III | Dr. Reddy's Laboratories, Inc.D-0219-2026 | Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit. | Validation & Qualification |
| 2025-12-17 | Class II | Cipla USA, Inc.D-0224-2026 | CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits. | Validation & Qualification |
| 2025-12-17 | Class II | Cipla USA, Inc.D-0226-2026 | CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits. | Validation & Qualification |
| 2025-12-17 | Class II | Cipla USA, Inc.D-0225-2026 | CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits. | Validation & Qualification |
| 2025-12-10 | Class II | Cipla LimitedD-0197-2026 | Failed Stability Specifications: Observed OOS results: eg results for colour index | Validation & Qualification |
| 2025-12-10 | Class II | Breckenridge Pharmaceutical, Inc.D-0216-2026 | CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit | Validation & Qualification |
| 2025-12-10 | Class II | Breckenridge Pharmaceutical, Inc.D-0215-2026 | CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit | Validation & Qualification |
| 2025-11-26 | Class III | Imprimis NJOF, LLCD-0157-2026 | Subpotent Drug | Validation & Qualification |
| 2025-11-26 | Class II | Zydus Pharmaceuticals (USA) IncD-0159-2026 | Failed Impurities/Degradation Specifications: Out of Specification (OOS) result reported for 2- Bromoergine impurity of Bromocriptine Mesylate Capsules. | Validation & Qualification |
| 2025-11-26 | Class III | Alembic Pharmaceuticals LimitedD-0156-2026 | Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit. | Validation & Qualification |
| 2025-11-26 | Class II | Golden State Medical Supply Inc.D-0158-2026 | Failed Dissolution Specifications | Validation & Qualification |
| 2025-11-12 | Class II | Zydus Pharmaceuticals (USA) IncD-0152-2026 | 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 |
| 2025-11-12 | Class II | Teva Pharmaceuticals USA, IncD-0151-2026 | Subpotent drug; Clavulanate Potassium component | Validation & Qualification |
| 2025-11-12 | Class II | Zydus Pharmaceuticals (USA) IncD-0154-2026 | 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 |
| 2025-11-12 | 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 | 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-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 | 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 | 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 | 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 | 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 | Amerisource Health Services LLCD-0103-2026 | 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 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 | 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 |
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.