[ 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.
1,235 matching recalls
| Date | Class | Firm | Reason | Quality domain |
|---|---|---|---|---|
| 2026-04-08 | Class II | K.C. Pharmaceuticals, IncD-0409-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2026-04-08 | Class II | JFE FRANCHISING INCH-0638-2026 | Foreign Object (Glass) | Environmental Monitoring |
| 2026-04-08 | Class II | JFE FRANCHISING INCH-0639-2026 | Foreign Object (Glass) | Environmental Monitoring |
| 2026-04-08 | Class I | Lone Star Dairy Products LLCH-0640-2026 | Salmonella spp. identified in finished product testing | Environmental Monitoring |
| 2026-04-01 | Class II | Teva Pharmaceuticals USA, IncD-0406-2026 | Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer. | Environmental Monitoring |
| 2026-04-01 | Class II | Pacific Coast Fresh COH-0609-2026 | Foreign material (aluminum pieces). | Environmental Monitoring |
| 2026-04-01 | Class II | Pacific Coast Fresh COH-0606-2026 | Foreign material (aluminum pieces). | Environmental Monitoring |
| 2026-04-01 | Class II | American Laboratories, LLCH-0611-2026 | Potential Salmonella contamination. | Environmental Monitoring |
| 2026-04-01 | Class II | Sevillo Fine Foods, IncH-0616-2026 | Product may contain foreign material (metal fragments). | Environmental Monitoring |
| 2026-04-01 | Class II | American Laboratories, LLCH-0610-2026 | Potential Salmonella contamination. | Environmental Monitoring |
| 2026-04-01 | Class II | BakkavorH-0618-2026 | Metal fragments in bread. The firm discovered metal fragments in various bread products. They determined the cause to be roasted tomatoes provided by one of their ingredient suppliers. | Environmental Monitoring |
| 2026-04-01 | Class II | Pacific Coast Fresh COH-0607-2026 | Foreign material (aluminum pieces). | Environmental Monitoring |
| 2026-04-01 | Class II | Ajinomoto Foods North America Inc.H-0601-2026 | Foreign objects are glass varying in size from 1-3cm long and 2-4mm wide. | Environmental Monitoring |
| 2026-04-01 | Class II | Ajinomoto Foods North America Inc.H-0591-2026 | Foreign objects are glass varying in size from 1-3cm long and 2-4mm wide. | Environmental Monitoring |
| 2026-04-01 | Class II | Medline Industries, LPZ-1650-2026 | Elevated endotoxin levels identified in affected lots. Issue may elicit strong inflammatory response if used, including local tissue irritation, delayed wound healing, or systemic effects such as fever and hypotension. In severe cases, septic shock may result. | Environmental Monitoring |
| 2026-04-01 | Class II | Beckman Coulter, Inc.Z-1609-2026 | Due to the likely presence of contamination in well(s). | Environmental Monitoring |
| 2026-04-01 | Class II | Western Mixers Produce & Nuts, Inc.H-0589-2026 | Foreign object (glass) found inside sealed container of finished product. | Environmental Monitoring |
| 2026-04-01 | Class II | Sevillo Fine Foods, IncH-0617-2026 | Product may contain foreign material (metal fragments). | Environmental Monitoring |
| 2026-04-01 | Class II | Chiesi USA, Inc.D-0402-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2026-04-01 | Class II | Teva Pharmaceuticals USA, IncD-0405-2026 | Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer. | Environmental Monitoring |
| 2026-04-01 | Class II | Pacific Coast Fresh COH-0604-2026 | Foreign material (aluminum pieces). | Environmental Monitoring |
| 2026-04-01 | Class II | Ajinomoto Foods North America Inc.H-0593-2026 | Foreign objects are glass varying in size from 1-3cm long and 2-4mm wide. | Environmental Monitoring |
| 2026-04-01 | Class II | Teva Pharmaceuticals USA, IncD-0404-2026 | Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer. | Environmental Monitoring |
| 2026-04-01 | Class II | American Laboratories, LLCH-0612-2026 | Potential Salmonella contamination. | Environmental Monitoring |
| 2026-04-01 | Class II | Pacific Coast Fresh COH-0605-2026 | Foreign material (aluminum pieces). | 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.