[ 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 |
|---|---|---|---|---|
| 2025-11-05 | Class II | FARMAKEIO OUTSOURCING LLCD-0130-2026 | CGMP Deviations: Potential presence of metal particulate matter | Environmental Monitoring |
| 2025-11-05 | Class II | FARMAKEIO OUTSOURCING LLCD-0126-2026 | CGMP Deviations: Potential presence of metal particulate matter | Environmental Monitoring |
| 2025-11-05 | Class II | FARMAKEIO OUTSOURCING LLCD-0129-2026 | CGMP Deviations: Potential presence of metal particulate matter | Environmental Monitoring |
| 2025-11-05 | Class II | FARMAKEIO OUTSOURCING LLCD-0134-2026 | CGMP Deviations: Potential presence of metal particulate matter | Environmental Monitoring |
| 2025-11-05 | Class II | ProRx LLCD-0118-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2025-11-05 | Class II | FARMAKEIO OUTSOURCING LLCD-0127-2026 | CGMP Deviations: Potential presence of metal particulate matter | Environmental Monitoring |
| 2025-11-05 | Class II | ProRx LLCD-0115-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2025-11-05 | Class II | FARMAKEIO OUTSOURCING LLCD-0133-2026 | CGMP Deviations: Potential presence of metal particulate matter | Environmental Monitoring |
| 2025-11-05 | Class II | FARMAKEIO OUTSOURCING LLCD-0128-2026 | CGMP Deviations: Potential presence of metal particulate matter | Environmental Monitoring |
| 2025-11-05 | Class II | FARMAKEIO OUTSOURCING LLCD-0137-2026 | CGMP Deviations: Potential presence of metal particulate matter | Environmental Monitoring |
| 2025-11-05 | Class II | FARMAKEIO OUTSOURCING LLCD-0123-2026 | CGMP Deviations: Potential presence of metal particulate matter | Environmental Monitoring |
| 2025-11-05 | Class II | Otsuka ICU Medical LLCD-0143-2026 | Lack of Assurance of Sterility: Potential for flexible container leaks. | Environmental Monitoring |
| 2025-11-05 | Class II | ProRx LLCD-0119-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2025-11-05 | Class II | FARMAKEIO OUTSOURCING LLCD-0132-2026 | CGMP Deviations: Potential presence of metal particulate matter | Environmental Monitoring |
| 2025-11-05 | Class II | FARMAKEIO OUTSOURCING LLCD-0136-2026 | CGMP Deviations: Potential presence of metal particulate matter | Environmental Monitoring |
| 2025-11-05 | Class II | Samsung Bioepis Co., Ltd.D-0099-2026 | Lack of Assurance of Sterility. | Environmental Monitoring |
| 2025-11-05 | Class II | FARMAKEIO OUTSOURCING LLCD-0124-2026 | CGMP Deviations: Potential presence of metal particulate matter | Environmental Monitoring |
| 2025-11-05 | Class II | FARMAKEIO OUTSOURCING LLCD-0131-2026 | CGMP Deviations: Potential presence of metal particulate matter | Environmental Monitoring |
| 2025-11-05 | Class II | ProRx LLCD-0116-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2025-10-29 | Class I | Reser's Fine Foods, Inc.H-0090-2026 | Salad Kits are recalled due to potential contamination with Listeria monocytogenes. | Environmental Monitoring |
| 2025-10-29 | Class I | DEMERS FOOD GROUP LLCH-0132-2026 | Contains Linguine manufactured by Nate's Fine Foods LLC recalled for Listeria monocytogenes and implicated in ongoing outbreak | Environmental Monitoring |
| 2025-10-29 | Class II | Ocean's Kitchen Corp.H-0140-2026 | The potential contamination with Clostridium botulinum, due to risk of temperature abuse during chilled storage at the firm. | Environmental Monitoring |
| 2025-10-29 | Class II | Southwind Foods LLC dba Great American Seafood Imports Co.H-0112-2026 | Product manufactured under insanitary conditions whereby it may have been contaminated with Cesium-137 (Cs-137). This is an expansion to the original recall. | Environmental Monitoring |
| 2025-10-29 | Class I | M.C.I. Foods, Inc.H-0149-2026 | Cooked egg ingredient for Ready-to-Eat products tested positive for Listeria Monocytogenes | Environmental Monitoring |
| 2025-10-29 | Class I | Giant Eagle, Inc.H-0086-2026 | Recall notification from supplier of Potential listeria contamination. | 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.