[ 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 |
|---|---|---|---|---|
| 2026-01-14 | Class I | Medinatura New Mexico, inc.D-0289-2026 | Microbial Contamination of Non-Sterile Products: The products have been found to contain yeast/mold and microbial contamination identified as Achromobacter. | Environmental Monitoring |
| 2026-01-14 | Class I | Medinatura New Mexico, inc.D-0288-2026 | Microbial Contamination of Non-Sterile Products: The products have been found to contain yeast/mold and microbial contamination identified as Achromobacter. | Environmental Monitoring |
| 2026-01-14 | Class II | Imprimis NJOF, LLCD-0250-2026 | Presence of particulate matter - Glass like particles. | Environmental Monitoring |
| 2026-01-14 | Class II | Imprimis NJOF, LLCD-0249-2026 | Presence of particulate matter - Glass like particles. | Environmental Monitoring |
| 2026-01-07 | Class II | Glenmark Pharmaceuticals Inc., USAD-0246-2026 | Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and tablets falling out. Preferred Pharmaceuticals purchased the finished product and repackaged the product for sale. | Documentation & Change Control |
| 2026-01-07 | Class II | Novo Nordisk Inc.D-0245-2026 | Presence of Particulate Matter: Hair was found in a prefilled syringe | Environmental Monitoring |
| 2026-01-07 | Class II | Novo Nordisk Inc.D-0244-2026 | Presence of Particulate Matter: Hair was found in a prefilled syringe | Environmental Monitoring |
| 2026-01-07 | Class II | CareFusion 213, LLCD-0243-2026 | Lack of Assurance of Sterlity | — |
| 2026-01-07 | Class III | Zydus Pharmaceuticals (USA) IncD-0247-2026 | Failed Tablet/Capsule Specifications: Product complaint received that some tablets had a dent on the plain side of the tablet surface. | — |
| 2025-12-31 | Class II | Merck Sharp & Dohme LLCD-0241-2026 | Presence of particulate matter: potential presence of metal particulates in the product. | Environmental Monitoring |
| 2025-12-31 | Class II | Merck Sharp & Dohme LLCD-0242-2026 | Presence of particulate matter: potential presence of metal particulates in the product. | Environmental Monitoring |
| 2025-12-24 | Class III | SOMERSET THERAPEUTICS LLCD-0238-2026 | Subpotent product:out of specification assay results observed during long term stability testing. | Validation & Qualification |
| 2025-12-24 | Class II | Novocol Pharmaceutical of Canada, Inc.D-0228-2026 | Defective container: cracked/broken cartridges | — |
| 2025-12-24 | Class II | SUN PHARMA /TAROD-0240-2026 | Failed Impurity/Degradation specifications: OOS results obtained at the 18-month timepoint | Validation & Qualification |
| 2025-12-24 | Class II | Golden State Medical Supply Inc.D-0235-2026 | Presence of Foreign Tablets/Capsules | — |
| 2025-12-24 | Class II | Preferred Pharmaceuticals, Inc.D-0239-2026 | Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and tablets falling out. Preferred Pharmaceuticals purchased the finished product and repackaged the product for sale. | Documentation & Change Control |
| 2025-12-24 | Class II | Novocol Pharmaceutical of Canada, Inc.D-0232-2026 | Defective container: cracked/broken cartridges | — |
| 2025-12-24 | Class II | Novocol Pharmaceutical of Canada, Inc.D-0230-2026 | Defective container: cracked/broken cartridges | — |
| 2025-12-24 | Class III | SOMERSET THERAPEUTICS LLCD-0237-2026 | Subpotent product:out of specification assay results observed during long term stability testing. | Validation & Qualification |
| 2025-12-24 | Class II | Novocol Pharmaceutical of Canada, Inc.D-0234-2026 | Defective container: cracked/broken cartridges | — |
| 2025-12-24 | Class II | Novocol Pharmaceutical of Canada, Inc.D-0233-2026 | Defective container: cracked/broken cartridges | — |
| 2025-12-24 | Class II | Novocol Pharmaceutical of Canada, Inc.D-0229-2026 | Defective container: cracked/broken cartridges | — |
| 2025-12-24 | Class II | Novocol Pharmaceutical of Canada, Inc.D-0231-2026 | Defective container: cracked/broken cartridges | — |
| 2025-12-24 | Class III | SOMERSET THERAPEUTICS LLCD-0236-2026 | Subpotent product:out of specification assay results observed during long term stability testing. | Validation & Qualification |
| 2025-12-17 | Class II | Fagron Compounding ServicesD-0221-2026 | Incorrect Product Formulation | Documentation & Change Control |
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.