[ 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 |
|---|---|---|---|---|
| 2025-11-12 | Class II | Admiralty Island Fisheries Inc dba AquaStar (USA) Corp.H-0165-2026 | Shrimp may be contaminated with Cesium-137 (Cs-137). | Environmental Monitoring |
| 2025-11-12 | Class II | Admiralty Island Fisheries Inc dba AquaStar (USA) Corp.H-0163-2026 | Shrimp may be contaminated with Cesium-137 (Cs-137). | Environmental Monitoring |
| 2025-11-12 | Class II | Admiralty Island Fisheries Inc dba AquaStar (USA) Corp.H-0160-2026 | Shrimp may be contaminated with Cesium-137 (Cs-137). | Environmental Monitoring |
| 2025-11-12 | Class I | Kenz Henz LLCH-0170-2026 | Eggs may be contaminated with Salmonella. | Environmental Monitoring |
| 2025-11-12 | Class II | Admiralty Island Fisheries Inc dba AquaStar (USA) Corp.H-0157-2026 | Shrimp may be contaminated with Cesium-137 (Cs-137). | Environmental Monitoring |
| 2025-11-12 | Class II | Admiralty Island Fisheries Inc dba AquaStar (USA) Corp.H-0162-2026 | Shrimp may be contaminated with Cesium-137 (Cs-137). | Environmental Monitoring |
| 2025-11-12 | Class II | Ice Cream Factory, LLCH-0166-2026 | Foreign material fragments consisting of aluminum foil and packaging material were identified in brown sugar ingredient that may have been used in the products | Environmental Monitoring |
| 2025-11-12 | Class II | Admiralty Island Fisheries Inc dba AquaStar (USA) Corp.H-0158-2026 | Shrimp may be contaminated with Cesium-137 (Cs-137). | Environmental Monitoring |
| 2025-11-12 | Class II | Ice Cream Factory, LLCH-0167-2026 | Foreign material fragments consisting of aluminum foil and packaging material were identified in brown sugar ingredient that may have been used in the products | Environmental Monitoring |
| 2025-11-12 | Class I | EGGS UNLIMITED LLCH-0171-2026 | Firm received, repackaged eggs that are potentially contamination with Salmonella. | Environmental Monitoring |
| 2025-11-12 | Class II | Admiralty Island Fisheries Inc dba AquaStar (USA) Corp.H-0159-2026 | Shrimp may be contaminated with Cesium-137 (Cs-137). | Environmental Monitoring |
| 2025-11-12 | Class I | Jacob KingH-0153-2026 | Product may be contaminated with Salmonella | Environmental Monitoring |
| 2025-11-12 | Class II | Dr. Praeger's Sensible Foods Inc.H-0151-2026 | Product was made on equipment that test positive for Listeria . | Environmental Monitoring |
| 2025-11-12 | Class II | Admiralty Island Fisheries Inc dba AquaStar (USA) Corp.H-0164-2026 | Shrimp may be contaminated with Cesium-137 (Cs-137). | Environmental Monitoring |
| 2025-11-12 | Class II | Admiralty Island Fisheries Inc dba AquaStar (USA) Corp.H-0161-2026 | Shrimp may be contaminated with Cesium-137 (Cs-137). | Environmental Monitoring |
| 2025-11-05 | Class II | ProRx LLCD-0120-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2025-11-05 | Class II | E.A. Sween Co.H-0144-2026 | Potential foreign material (plastic) | Environmental Monitoring |
| 2025-11-05 | Class II | Nate's Fine Foods, LLCH-0142-2026 | Potential contamination with Listeria monocytogenes. | Environmental Monitoring |
| 2025-11-05 | Class II | FreshRealm, IncH-0141-2026 | Potential contamination with listeria monocytogenes | Environmental Monitoring |
| 2025-11-05 | Class I | Echo Lake Foods, Inc.H-0168-2026 | Potential Listeria monocytogenes contamination. | Environmental Monitoring |
| 2025-11-05 | Class II | ProRx LLCD-0117-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2025-11-05 | Class II | FARMAKEIO OUTSOURCING LLCD-0125-2026 | CGMP Deviations: Potential presence of metal particulate matter | Environmental Monitoring |
| 2025-11-05 | Class II | ProRx LLCD-0114-2026 | Lack of Assurance of Sterility | Environmental Monitoring |
| 2025-11-05 | Class II | QuVa Pharma, Inc.D-0113-2026 | Presence of Particulate Matter | Environmental Monitoring |
| 2025-11-05 | Class II | FARMAKEIO OUTSOURCING LLCD-0135-2026 | CGMP Deviations: Potential presence of metal particulate matter | 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.