[ 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 |
|---|---|---|---|---|
| 2025-09-03 | Class I | CHETAK NEW YORK LLCH-0574-2025 | Product tested positive Salmonella . | Environmental Monitoring |
| 2025-09-03 | Class II | H & N Group Inc.H-0548-2025 | Product manufactured under insanitary conditions whereby it may have been contaminated with Cesium-137 (Cs-137) | Environmental Monitoring |
| 2025-09-03 | Class II | The J.M. Smucker CompanyH-0577-2025 | Mold. The firm noticed an increase in customer complaints. They conducted a root cause investigation and discovered that one of their coolers had malfunctioning. | Environmental Monitoring |
| 2025-09-03 | Class II | Beaver Street Fisheries, Inc.H-0549-2025 | Product may be contaminated with Cesium-137 (Cs-137) | Environmental Monitoring |
| 2025-09-03 | Class I | Middlefield Original Cheese CooperativeH-0528-2025 | Potential contamination with Listeria monocytogenes | Environmental Monitoring |
| 2025-09-03 | Class I | Middlefield Original Cheese CooperativeH-0530-2025 | Potential contamination with Listeria monocytogenes | Environmental Monitoring |
| 2025-09-03 | Class I | NEW ACAI AMAZONAS LLCH-0538-2025 | Potential Salmonella contamination | Environmental Monitoring |
| 2025-09-03 | Class I | Middlefield Original Cheese CooperativeH-0527-2025 | Potential contamination with Listeria monocytogenes | Environmental Monitoring |
| 2025-09-03 | Class I | Fromi UsaH-0547-2025 | Product may be contaminated with Listeria monocytogenes | Environmental Monitoring |
| 2025-09-03 | Class I | CHETAK NEW YORK LLCH-0575-2025 | Product tested positive Salmonella . | Environmental Monitoring |
| 2025-09-03 | Class I | Middlefield Original Cheese CooperativeH-0529-2025 | Potential contamination with Listeria monocytogenes | Environmental Monitoring |
| 2025-08-27 | Class II | Khee Trading, Inc.H-0520-2025 | Imported Frozen Oyster potentially contaminated with Norovirus. | Environmental Monitoring |
| 2025-08-27 | Class II | Khee Trading, Inc.H-0521-2025 | Imported Frozen Oyster potentially contaminated with Norovirus. | Environmental Monitoring |
| 2025-08-27 | Class II | Taizhou Kangping Medical Science And Technology Co., Ltd.D-0589-2025 | Lack of Assurance of Sterility. | Environmental Monitoring |
| 2025-08-27 | Class II | PFIZER INCD-0591-2025 | Lack of Assurance of Sterility. | Environmental Monitoring |
| 2025-08-27 | Class II | PFIZER INCD-0590-2025 | Lack of Assurance of Sterility. | Environmental Monitoring |
| 2025-08-20 | Class I | Albertsons Companies LLCH-0476-2025 | Potential contamination with Listeria monocytogenes. | Environmental Monitoring |
| 2025-08-20 | Class II | Jayone Foods, Inc.H-0500-2025 | Frozen Oyster product is potentially contaminated with Norovirus | Environmental Monitoring |
| 2025-08-20 | Class I | Reser's Fine Foods, Inc.H-0542-2025 | Tuna Salad products are recalled due to potential contamination with Listeria monocytogenes because products containing Newly Weds Foods recalled Japanese Style Breadcrumbs. | Environmental Monitoring |
| 2025-08-20 | Class I | Reser's Fine Foods, Inc.H-0545-2025 | Tuna Salad products are recalled due to potential contamination with Listeria monocytogenes because products containing Newly Weds Foods recalled Japanese Style Breadcrumbs. | Environmental Monitoring |
| 2025-08-20 | Class I | Albertsons Companies LLCH-0473-2025 | Potential contamination with Listeria monocytogenes. | Environmental Monitoring |
| 2025-08-20 | Class I | Reser's Fine Foods, Inc.H-0541-2025 | Tuna Salad products are recalled due to potential contamination with Listeria monocytogenes because products containing Newly Weds Foods recalled Japanese Style Breadcrumbs. | Environmental Monitoring |
| 2025-08-20 | Class I | Albertsons Companies LLCH-0480-2025 | Potential contamination with Listeria monocytogenes. | Environmental Monitoring |
| 2025-08-20 | Class I | Albertsons Companies LLCH-0479-2025 | Potential contamination with Listeria monocytogenes. | Environmental Monitoring |
| 2025-08-20 | Class I | Albertsons Companies LLCH-0472-2025 | Potential contamination with Listeria monocytogenes. | 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.