[ 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 |
|---|---|---|---|---|
| 2025-10-15 | Class II | GenoGenix LLCD-0076-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2025-10-15 | Class II | GenoGenix LLCD-0086-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2025-10-15 | Class II | GenoGenix LLCD-0090-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2025-10-15 | Class II | GenoGenix LLCD-0045-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2025-10-15 | Class II | GenoGenix LLCD-0083-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2025-10-15 | Class I | Nate's Fine Foods, LLCH-0080-2026 | Potential contamination with Listeria monocytogenes. | Environmental Monitoring |
| 2025-10-15 | Class II | GenoGenix LLCD-0071-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2025-10-15 | Class I | Nate's Fine Foods, LLCH-0078-2026 | Potential contamination with Listeria monocytogenes. | Environmental Monitoring |
| 2025-10-15 | Class I | Nate's Fine Foods, LLCH-0081-2026 | Potential contamination with Listeria monocytogenes. | Environmental Monitoring |
| 2025-10-15 | Class II | M.O.M Enterprises, LLC.H-0025-2026 | Potential yeast contamination. | Environmental Monitoring |
| 2025-10-15 | Class II | Organicare Nature's Science, LLCH-0031-2026 | Microbial contamination with Escherichia coli O7:K1 and E. Coli 1303. | Environmental Monitoring |
| 2025-10-15 | Class I | Western United Fish Company IncH-0023-2026 | Listeria monocytogenes. Recall was initiated after being notified by green onion supplier of a Listeria monocytogenes positive test result in the green onions which were used only in Ahi Tuna Wasabi Poke. | Environmental Monitoring |
| 2025-10-15 | Class II | GenoGenix LLCD-0058-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2025-10-15 | Class II | GenoGenix LLCD-0082-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2025-10-15 | Class I | New Age International, Inc.H-0026-2026 | Product may be contaminated with Listeria monocytogenes. | Environmental Monitoring |
| 2025-10-15 | Class II | RC Outsourcing, LLCD-0003-2026 | Lack of assurance of sterility. | Environmental Monitoring |
| 2025-10-15 | Class II | GenoGenix LLCD-0038-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2025-10-15 | Class I | GenoGenix LLCD-0094-2026 | Microbial Contamination of Sterile Products: elevated endotoxin levels | Environmental Monitoring |
| 2025-10-15 | Class II | GenoGenix LLCD-0070-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2025-10-15 | Class II | GenoGenix LLCD-0089-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2025-10-15 | Class II | GenoGenix LLCD-0078-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2025-10-15 | Class II | GenoGenix LLCD-0047-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2025-10-15 | Class II | GenoGenix LLCD-0050-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2025-10-15 | Class II | GenoGenix LLCD-0075-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2025-10-15 | Class II | GenoGenix LLCD-0074-2026 | Lack of Assurance of Sterility | 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.