[ 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.
1,475 matching recalls
| Date | Class | Firm | Reason | Quality domain |
|---|---|---|---|---|
| 2025-10-01 | Class I | Middlefield Original Cheese CooperativeH-0629-2025 | Potential contamination with Listeria monocytogenes | Environmental Monitoring |
| 2025-10-01 | Class III | SUNGAL INCH-0636-2025 | Cyclamate adulteration | Risk Management & CAPA |
| 2025-10-01 | Class III | Mothers' Milk Bank of AlabamaH-0634-2025 | Potential physical contaminant | — |
| 2025-10-01 | Class II | Extract Labs, Inc.H-0624-2025 | Potential peanut protein cross-contact. | — |
| 2025-10-01 | Class I | Middlefield Original Cheese CooperativeH-0633-2025 | Potential contamination with Listeria monocytogenes | Environmental Monitoring |
| 2025-10-01 | Class I | Middlefield Original Cheese CooperativeH-0632-2025 | Potential contamination with Listeria monocytogenes | Environmental Monitoring |
| 2025-10-01 | Class II | Extract Labs, Inc.H-0621-2025 | Potential peanut protein cross-contact. | — |
| 2025-10-01 | Class I | Gooder Foods, Inc.H-0028-2026 | Undeclared allergens (cashews). | Documentation & Change Control |
| 2025-10-01 | Class II | Extract Labs, Inc.H-0623-2025 | Potential peanut protein cross-contact. | — |
| 2025-09-24 | Class III | Hi-Tech Pharmaceuticals Inc.H-0593-2025 | Unapproved Drug Claims and Misbranded. | Documentation & Change Control |
| 2025-09-24 | Class III | E&E Foods IncH-0620-2025 | Goldband Snapper is recalled because testing confirmed fish is Sharptooth Snapper. | — |
| 2025-09-24 | Class I | Fresh & Ready Foods LLCH-0615-2025 | undeclared allergen (Wheat) on ready to eat sandwiches. | Documentation & Change Control |
| 2025-09-24 | Class I | Fresh & Ready Foods LLCH-0614-2025 | undeclared allergen (Wheat and Milk) on ready to eat sandwiches. | Documentation & Change Control |
| 2025-09-24 | Class III | Hi-Tech Pharmaceuticals Inc.H-0595-2025 | Unapproved Drug Claims. | Documentation & Change Control |
| 2025-09-24 | Class III | Hi-Tech Pharmaceuticals Inc.H-0598-2025 | Unapproved Drug Claims and Misbranded. | Documentation & Change Control |
| 2025-09-24 | Class II | Wang GlobalnetH-0611-2025 | Oyster product potentially contaminated with Norovirus | Environmental Monitoring |
| 2025-09-24 | Class II | Admiralty Island Fisheries Inc dba AquaStar (USA) Corp.H-0585-2025 | Product may be contaminated with Cesium-137 (Cs-137). | Environmental Monitoring |
| 2025-09-24 | Class III | Hi-Tech Pharmaceuticals Inc.H-0588-2025 | Unapproved Drug Claims and Misbranded. | Documentation & Change Control |
| 2025-09-24 | Class I | Fresh & Ready Foods LLCH-0613-2025 | undeclared allergen (Wheat and Milk) on ready to eat sandwiches. | Documentation & Change Control |
| 2025-09-24 | Class I | Endico Potatoes IncH-0617-2025 | Product may be contaminated with Listeria monocytogenes. | Environmental Monitoring |
| 2025-09-24 | Class II | Southwind Foods LLC dba Great American Seafood Imports Co.H-0604-2025 | Product manufactured under insanitary conditions whereby it may have been contaminated with Cesium-137 (Cs-137) | Environmental Monitoring |
| 2025-09-24 | Class III | Hi-Tech Pharmaceuticals Inc.H-0589-2025 | Unapproved Drug Claims. | Documentation & Change Control |
| 2025-09-24 | Class I | PRIMO NO. 1 IN PRODUCE, INCH-0606-2025 | Product contaminated with Salmonella | Environmental Monitoring |
| 2025-09-24 | Class II | Admiralty Island Fisheries Inc dba AquaStar (USA) Corp.H-0584-2025 | Product may be contaminated with Cesium-137 (Cs-137). | Environmental Monitoring |
| 2025-09-24 | Class II | Admiralty Island Fisheries Inc dba AquaStar (USA) Corp.H-0583-2025 | Product may be contaminated with Cesium-137 (Cs-137). | 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.