[ 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
214
Class I (most serious)
167
Drug
520
Device
313
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 |
|---|---|---|---|---|
| 2025-08-06 | Class I | Newly Weds Foods, Inc.H-0433-2025 | potential Listeria Monocytogenes Contamination | Environmental Monitoring |
| 2025-08-06 | Class I | Newly Weds Foods, Inc.H-0432-2025 | 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 |
| 2025-08-06 | Class I | Newly Weds Foods, Inc.H-0428-2025 | potential Listeria Monocytogenes Contamination | Environmental Monitoring |
| 2025-08-06 | Class I | Newly Weds Foods, Inc.H-0434-2025 | potential Listeria Monocytogenes Contamination | Environmental Monitoring |
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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.