[ 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 |
|---|---|---|---|---|
| 2025-08-20 | Class II | PAX Spices & Labs IncH-0457-2025 | Foreign object (metal) in granulated onion ingredient. | Environmental Monitoring |
| 2025-08-20 | Class I | Albertsons Companies LLCH-0481-2025 | Potential contamination with Listeria monocytogenes. | Environmental Monitoring |
| 2025-08-20 | Class II | B BRAUN MEDICAL INCD-0585-2025 | Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites. | Environmental Monitoring |
| 2025-08-13 | Class I | W.W. Industrial Group, Inc.H-0387-2025 | Contaminated with elevated lead and cadmium | Environmental Monitoring |
| 2025-08-13 | Class I | King Cheesecake Company, Inc.H-0419-2025 | Pecans have the potential to be contaminated with Salmonella | Environmental Monitoring |
| 2025-08-13 | Class I | King Cheesecake Company, Inc.H-0421-2025 | Pecans have the potential to be contaminated with Salmonella | Environmental Monitoring |
| 2025-08-13 | Class I | King Cheesecake Company, Inc.H-0422-2025 | Pecans have the potential to be contaminated with Salmonella | Environmental Monitoring |
| 2025-08-13 | Class I | King Cheesecake Company, Inc.H-0420-2025 | Pecans have the potential to be contaminated with Salmonella | Environmental Monitoring |
| 2025-08-13 | Class I | King Cheesecake Company, Inc.H-0424-2025 | Pecans have the potential to be contaminated with Salmonella | Environmental Monitoring |
| 2025-08-13 | Class I | King Cheesecake Company, Inc.H-0423-2025 | Pecans have the potential to be contaminated with Salmonella | Environmental Monitoring |
| 2025-08-13 | Class II | Louisa Food Products, Inc.H-0389-2025 | Supplier recalled ingredient used in finished product for possible Listeria monocytogenes contamination | Environmental Monitoring |
| 2025-08-13 | Class I | Krasnyi Oktyabr USA IncH-0391-2025 | Clostridium botulinum (uneviscerated fish) | Environmental Monitoring |
| 2025-08-13 | Class I | Doehler North America, Inc.H-0394-2025 | Listeria monocytogenes. During routine testing the firm received positive test results for Listeria monocytogenes. | Environmental Monitoring |
| 2025-08-13 | Class II | GIVE AND GO PREPARED FOODS CORPH-0385-2025 | Foreign Material (wood) | Environmental Monitoring |
| 2025-08-13 | Class I | Navarro Pecan Holdings, LLCH-0379-2025 | Pecans have the potential to be contaminated with Salmonella, | Environmental Monitoring |
| 2025-08-06 | Class I | Newly Weds Foods, Inc.H-0437-2025 | potential Listeria Monocytogenes Contamination | Environmental Monitoring |
| 2025-08-06 | Class I | Newly Weds Foods, Inc.H-0426-2025 | potential Listeria Monocytogenes Contamination | Environmental Monitoring |
| 2025-08-06 | Class I | Newly Weds Foods, Inc.H-0431-2025 | potential Listeria Monocytogenes Contamination | Environmental Monitoring |
| 2025-08-06 | Class I | Newly Weds Foods, Inc.H-0439-2025 | potential Listeria Monocytogenes Contamination | Environmental Monitoring |
| 2025-08-06 | Class I | Newly Weds Foods, Inc.H-0440-2025 | potential Listeria Monocytogenes Contamination | Environmental Monitoring |
| 2025-08-06 | Class I | Newly Weds Foods, Inc.H-0436-2025 | potential Listeria Monocytogenes Contamination | Environmental Monitoring |
| 2025-08-06 | Class I | Newly Weds Foods, Inc.H-0430-2025 | potential Listeria Monocytogenes Contamination | Environmental Monitoring |
| 2025-08-06 | Class I | Newly Weds Foods, Inc.H-0435-2025 | potential Listeria Monocytogenes Contamination | Environmental Monitoring |
| 2025-08-06 | Class II | Pfizer Inc.D-0545-2025 | CGMP Deviations; particulates identified during visual inspection | Environmental Monitoring |
| 2025-08-06 | Class II | Pfizer Inc.D-0544-2025 | CGMP Deviations; particulates identified during visual inspection | 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.