[ 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.
1,232 matching recalls
| Date | Class | Firm | Reason | Quality domain |
|---|---|---|---|---|
| 2025-12-10 | Class II | Great Lakes Cheese Co IncH-0216-2026 | Potential metal fragments from supplier raw material (downstream recall) | Environmental Monitoring |
| 2025-12-10 | Class II | Hale incH-0241-2026 | Potential to be contaminated with Clostridium botulinum. Products manufactured without an approved process filed. | Environmental Monitoring |
| 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 | Great Lakes Cheese Co IncH-0219-2026 | Potential metal fragments from supplier raw material (downstream recall) | Environmental Monitoring |
| 2025-12-10 | Class II | VENTURA FOODS LLCH-0235-2026 | foreign objects (black plastic planting material) in granulated onion | Environmental Monitoring |
| 2025-12-03 | Class I | Fresenius Kabi USA, LLCD-0182-2026 | Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing. | Environmental Monitoring |
| 2025-12-03 | Class I | WFM Purchasing, LPH-0211-2026 | Twin Sisters Creamery's recall of cheese products due to WSDA testing that identified potential STEC and E. coli O103 contamination. Whole Foods Market received affected products through distributor Peterson Company and sold them by weight with store-generated labels. | Environmental Monitoring |
| 2025-12-03 | Class II | Medical Products Laboratories, Inc.D-0179-2026 | Microbial contamination of a non-sterile product - microorganism found to be pseudomonas lactis | Environmental Monitoring |
| 2025-12-03 | Class I | MeriCal, LLCH-0205-2026 | Potential contamination of Salmonella Richmond | Environmental Monitoring |
| 2025-12-03 | Class I | FRC INCH-0212-2026 | FDA environmental sample identified the presence of Listeria monocytogenes in the processing area where cheese was packaged. | Environmental Monitoring |
| 2025-12-03 | Class I | WFM Purchasing, LPH-0210-2026 | Twin Sisters Creamery's recall of cheese products due to WSDA testing that identified potential STEC and E. coli O103 contamination. Whole Foods Market received affected products through distributor Peterson Company and sold them by weight with store-generated labels. | Environmental Monitoring |
| 2025-11-26 | Class I | Twin Sisters Creamery, LLCH-0194-2026 | Raw milk Farmhouse cheeses are recalled due to E. coli O103:H2 and E. coli O74:H25. | Environmental Monitoring |
| 2025-11-26 | Class II | DermaRite Industries, LLCD-0174-2026 | CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated. | Environmental Monitoring |
| 2025-11-26 | Class I | Peterson Company IncH-0198-2026 | Item #29608 Farmhouse White is recalled due to E. coli O103:H2. | Environmental Monitoring |
| 2025-11-26 | Class II | DermaRite Industries, LLCD-0175-2026 | CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated. | Environmental Monitoring |
| 2025-11-26 | Class II | DermaRite Industries, LLCD-0177-2026 | CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated. | Environmental Monitoring |
| 2025-11-26 | Class I | Twin Sisters Creamery, LLCH-0195-2026 | Raw milk Peppercorn cheese is recalled due to E.coli O26:H11 | Environmental Monitoring |
| 2025-11-26 | Class I | Twin Sisters Creamery, LLCH-0196-2026 | Raw milk Mustard Seed cheese is recalled due to E. coli O103:H2 and E. coli O74:H25. | Environmental Monitoring |
| 2025-11-26 | Class II | DermaRite Industries, LLCD-0161-2026 | CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated. | Environmental Monitoring |
| 2025-11-26 | Class II | DermaRite Industries, LLCD-0160-2026 | CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated. | Environmental Monitoring |
| 2025-11-26 | Class II | DermaRite Industries, LLCD-0171-2026 | CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated. | Environmental Monitoring |
| 2025-11-26 | Class II | DermaRite Industries, LLCD-0169-2026 | CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated. | Environmental Monitoring |
| 2025-11-26 | Class II | DermaRite Industries, LLCD-0167-2026 | CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated. | Environmental Monitoring |
| 2025-11-26 | Class II | DermaRite Industries, LLCD-0166-2026 | CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated. | Environmental Monitoring |
| 2025-11-26 | Class I | New Hoque and Sons, Inc.H-0202-2026 | Un-eviscerated fish may be contaminated with Clostridia botulinum. | 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.