[ 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-0092-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2025-10-15 | Class II | GenoGenix LLCD-0088-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2025-10-15 | Class II | GenoGenix LLCD-0039-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2025-10-15 | Class II | GenoGenix LLCD-0049-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2025-10-15 | Class II | GenoGenix LLCD-0061-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2025-10-15 | Class II | GenoGenix LLCD-0072-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2025-10-15 | Class II | GenoGenix LLCD-0063-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2025-10-15 | Class II | GenoGenix LLCD-0065-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2025-10-15 | Class II | GenoGenix LLCD-0064-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2025-10-15 | Class II | GenoGenix LLCD-0057-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2025-10-15 | Class II | GenoGenix LLCD-0062-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2025-10-15 | Class II | GenoGenix LLCD-0051-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2025-10-15 | Class II | GenoGenix LLCD-0054-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2025-10-15 | Class II | GenoGenix LLCD-0081-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2025-10-15 | Class I | Nate's Fine Foods, LLCH-0075-2026 | Potential contamination with Listeria monocytogenes. | Environmental Monitoring |
| 2025-10-08 | Class I | Chefs WarehouseH-0644-2025 | Product is contaminated with Salmonella | Environmental Monitoring |
| 2025-10-08 | Class I | Chefs WarehouseH-0643-2025 | Product is contaminated with Salmonella | Environmental Monitoring |
| 2025-10-08 | Class II | Apotex Corp.D-0677-2025 | Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns | Environmental Monitoring |
| 2025-10-08 | Class II | Apotex Corp.D-0676-2025 | Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns | Environmental Monitoring |
| 2025-10-08 | Class I | Chefs WarehouseH-0642-2025 | Product is contaminated with Salmonella | Environmental Monitoring |
| 2025-10-08 | Class I | GOOT ESSA, LLCH-0647-2025 | The firm had a positive Listeria Monocytogenes on a sample from this batch of product made. | Environmental Monitoring |
| 2025-10-08 | Class I | Chefs WarehouseH-0646-2025 | Product is contaminated with Salmonella | Environmental Monitoring |
| 2025-10-08 | Class I | Chefs WarehouseH-0645-2025 | Product is contaminated with Salmonella | Environmental Monitoring |
| 2025-10-08 | Class II | Lawrence Wholesale LLCH-0638-2025 | Product manufactured under insanitary conditions whereby it may have been contaminated with Cesium-137 (Cs-137) | Environmental Monitoring |
| 2025-10-08 | Class II | Lawrence Wholesale LLCH-0639-2025 | Product manufactured under insanitary conditions whereby it may have been contaminated with Cesium-137 (Cs-137) | 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.