[ 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 |
|---|---|---|---|---|
| 2025-12-17 | 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-0225-2026 | 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 | Lupin Pharmaceuticals Inc.D-0227-2026 | Defective container - seal not adhering to bottles | — |
| 2025-12-17 | Class III | Glenmark Pharmaceuticals Inc., USAD-0222-2026 | Cross Contamination with Other Products | Environmental Monitoring |
| 2025-12-17 | Class III | Winder Laboratories, LLCD-0223-2026 | Correct Labeled Product Mispack-Size stated on carton label did not match the size of the bottle in the carton. | Documentation & Change Control |
| 2025-12-17 | Class II | Cipla USA, Inc.D-0218-2026 | Failed stability specifications: Out of specification for hardness test | Validation & Qualification |
| 2025-12-17 | Class II | Lupin Pharmaceuticals Inc.D-0220-2026 | Failed impurities/degradation specifications: out of specification results for Ganirelix acetate acrylic acid adduct impurity. | Validation & Qualification |
| 2025-12-17 | Class II | Cipla USA, Inc.D-0217-2026 | Failed stability specifications: Out of specification for hardness test | 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-0224-2026 | 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 | 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 | Blossom PharmaceuticalsD-0206-2026 | cGMP deviations | Risk Management & CAPA |
| 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 |
| 2025-12-10 | Class II | Blossom PharmaceuticalsD-0203-2026 | cGMP deviations | Risk Management & CAPA |
| 2025-12-10 | Class II | Safecor Health, LLCD-0214-2026 | Labeling: Not Elsewhere Classified:Incorrect RFID tag labels applied to product by repackaging firm. | Documentation & Change Control |
| 2025-12-10 | Class II | Blossom PharmaceuticalsD-0212-2026 | cGMP deviations | Risk Management & CAPA |
| 2025-12-10 | Class II | Blossom PharmaceuticalsD-0207-2026 | cGMP deviations | Risk Management & CAPA |
| 2025-12-10 | Class III | Glenmark Pharmaceuticals Inc., USAD-0199-2026 | Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe | Environmental Monitoring |
| 2025-12-10 | Class II | Park Avenue CompoundingD-0200-2026 | CGMP Deviations | Risk Management & CAPA |
| 2025-12-10 | Class II | Blossom PharmaceuticalsD-0202-2026 | cGMP deviations | Risk Management & CAPA |
| 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 III | Teva Pharmaceuticals USA, IncD-0198-2026 | Defective Container - A defect in the side-seal which allows leakage of product. | — |
| 2025-12-10 | Class II | Blossom PharmaceuticalsD-0210-2026 | cGMP deviations | Risk Management & CAPA |
| 2025-12-10 | Class II | Blossom PharmaceuticalsD-0211-2026 | cGMP deviations | Risk Management & CAPA |
| 2025-12-10 | Class II | Blossom PharmaceuticalsD-0205-2026 | cGMP deviations | 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.