[ 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 |
|---|---|---|---|---|
| 2025-10-08 | Class II | Gina Marie Bakery LLCH-0008-2026 | Undeclared Red 3 and Blue 1 | Documentation & Change Control |
| 2025-10-08 | Class I | Chefs WarehouseH-0642-2025 | Product is contaminated with Salmonella | Environmental Monitoring |
| 2025-10-08 | Class III | Stanley Pearlman Enterprises, Inc.H-0641-2025 | Recall initiated due to the wrong best by date (1-11-2025) being printed on the retail bag which would imply that these are expired but in truth they are good until 1-11-2027. | Validation & Qualification |
| 2025-10-08 | Class I | GOOT ESSA, LLCH-0647-2025 | The firm had a positive Listeria Monocytogenes on a sample from this batch of product made. | Environmental Monitoring |
| 2025-10-08 | Class III | Gina Marie Bakery LLCH-0007-2026 | Undeclared Red 40 | Documentation & Change Control |
| 2025-10-08 | Class I | Chefs WarehouseH-0644-2025 | Product is contaminated with Salmonella | Environmental Monitoring |
| 2025-10-08 | Class II | Lawrence Wholesale LLCH-0639-2025 | Product manufactured under insanitary conditions whereby it may have been contaminated with Cesium-137 (Cs-137) | Environmental Monitoring |
| 2025-10-08 | Class I | Chefs WarehouseH-0643-2025 | Product is contaminated with Salmonella | Environmental Monitoring |
| 2025-10-08 | Class II | Oven Artisans llcH-0001-2026 | Mislabeled: Product may contain undeclared sesame seeds | Documentation & Change Control |
| 2025-10-08 | Class II | Gina Marie Bakery LLCH-0003-2026 | Undeclared Almonds, Sesame, Red 40, Red 3, and Blue 1 | Documentation & Change Control |
| 2025-10-08 | Class I | Chefs WarehouseH-0645-2025 | Product is contaminated with Salmonella | Environmental Monitoring |
| 2025-10-08 | Class I | Chefs WarehouseH-0646-2025 | Product is contaminated with Salmonella | Environmental Monitoring |
| 2025-10-08 | Class II | Gina Marie Bakery LLCH-0004-2026 | Undeclared Sesame, Undeclared Yellow 5, Red 40, Yellow 6 | Documentation & Change Control |
| 2025-10-08 | Class II | Tas Tematic Foods IncH-0640-2025 | Product which was on FDA hold for high levels of Nitrofuran was inadvertently distributed. | — |
| 2025-10-08 | Class I | WFM Purchasing, LPH-0002-2026 | Product was incorrectly labeled, resulting in undeclared wheat, sesame, and cashew. | Documentation & Change Control |
| 2025-10-08 | Class II | Lawrence Wholesale LLCH-0638-2025 | Product manufactured under insanitary conditions whereby it may have been contaminated with Cesium-137 (Cs-137) | Environmental Monitoring |
| 2025-10-01 | Class I | Middlefield Original Cheese CooperativeH-0631-2025 | Potential contamination with Listeria monocytogenes | Environmental Monitoring |
| 2025-10-01 | Class I | Gooder Foods, Inc.H-0027-2026 | Undeclared allergens (milk). | Documentation & Change Control |
| 2025-10-01 | Class II | Domino Foods IncH-0637-2025 | Potential contamination with foreign objects. | Environmental Monitoring |
| 2025-10-01 | Class I | Middlefield Original Cheese CooperativeH-0627-2025 | Potential contamination with Listeria monocytogenes | Environmental Monitoring |
| 2025-10-01 | Class I | Middlefield Original Cheese CooperativeH-0630-2025 | Potential contamination with Listeria monocytogenes | Environmental Monitoring |
| 2025-10-01 | Class II | Extract Labs, Inc.H-0622-2025 | Potential peanut protein cross-contact. | — |
| 2025-10-01 | Class I | Middlefield Original Cheese CooperativeH-0626-2025 | Potential contamination with Listeria monocytogenes | Environmental Monitoring |
| 2025-10-01 | Class I | Middlefield Original Cheese CooperativeH-0625-2025 | Potential contamination with Listeria monocytogenes | Environmental Monitoring |
| 2025-10-01 | Class I | Middlefield Original Cheese CooperativeH-0628-2025 | 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.