[ 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-0091-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2025-10-15 | Class II | GenoGenix LLCD-0048-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2025-10-15 | Class II | GenoGenix LLCD-0060-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2025-10-15 | Class I | Nate's Fine Foods, LLCH-0076-2026 | Potential contamination with Listeria monocytogenes. | Environmental Monitoring |
| 2025-10-15 | Class II | GenoGenix LLCD-0044-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2025-10-15 | Class II | GenoGenix LLCD-0067-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2025-10-15 | Class II | GenoGenix LLCD-0093-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2025-10-15 | Class II | GenoGenix LLCD-0068-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2025-10-15 | Class II | GenoGenix LLCD-0079-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2025-10-15 | Class II | GenoGenix LLCD-0080-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2025-10-15 | Class II | GenoGenix LLCD-0040-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2025-10-15 | Class II | GenoGenix LLCD-0043-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2025-10-15 | Class II | GenoGenix LLCD-0059-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2025-10-15 | Class II | GenoGenix LLCD-0084-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2025-10-15 | Class II | GenoGenix LLCD-0073-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2025-10-15 | Class II | GenoGenix LLCD-0042-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2025-10-15 | Class II | GenoGenix LLCD-0077-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2025-10-15 | Class II | GenoGenix LLCD-0053-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2025-10-15 | Class II | GenoGenix LLCD-0052-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2025-10-15 | Class II | GenoGenix LLCD-0085-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2025-10-15 | Class II | GenoGenix LLCD-0069-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2025-10-15 | Class I | Nate's Fine Foods, LLCH-0079-2026 | Potential contamination with Listeria monocytogenes. | Environmental Monitoring |
| 2025-10-15 | Class II | GenoGenix LLCD-0055-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2025-10-15 | Class II | GenoGenix LLCD-0066-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2025-10-15 | Class II | GenoGenix LLCD-0046-2026 | 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.