[ 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 |
|---|---|---|---|---|
| 2025-12-10 | Class II | Great Lakes Cheese Co IncH-0217-2026 | Potential metal fragments from supplier raw material (downstream recall) | Environmental Monitoring |
| 2025-12-10 | Class II | Prime Food Processing LLC.H-0230-2026 | Products do not declare milk in the Contains statement or the ingredient statement. | — |
| 2025-12-10 | Class II | Great Lakes Cheese Co IncH-0216-2026 | Potential metal fragments from supplier raw material (downstream recall) | Environmental Monitoring |
| 2025-12-10 | Class II | Nutrition for LongevityH-0231-2026 | Potential contamination with Listeria monocytogenes. | Environmental Monitoring |
| 2025-12-10 | Class II | Dreyer's Grand Ice Cream, Inc.H-0227-2026 | Undeclared wheat. | Documentation & Change Control |
| 2025-12-10 | Class II | Great Lakes Cheese Co IncH-0215-2026 | Potential metal fragments from supplier raw material (downstream recall) | Environmental Monitoring |
| 2025-12-10 | Class II | Blonde Beard'sH-0223-2026 | Undeclared Soy | Documentation & Change Control |
| 2025-12-10 | Class II | Water Pure, Inc.H-0213-2026 | Product may be contaminated with E. coli O7:K1 (IAI39/ExPEC) and E. coli 1303 | Environmental Monitoring |
| 2025-12-10 | Class II | Rong Shing Trading NY IncH-0247-2026 | Product contains undeclared sulfites (7.39mg/serving) and cyclamates | Documentation & Change Control |
| 2025-12-10 | Class II | VENTURA FOODS LLCH-0235-2026 | foreign objects (black plastic planting material) in granulated onion | Environmental Monitoring |
| 2025-12-10 | Class II | Great Lakes Cheese Co IncH-0220-2026 | Potential metal fragments from supplier raw material (downstream recall) | Environmental Monitoring |
| 2025-12-10 | Class II | VENTURA FOODS LLCH-0236-2026 | foreign objects (black plastic planting material) in granulated onion | Environmental Monitoring |
| 2025-12-10 | Class II | Meadowgold Dairies Hawaii LLCH-0214-2026 | Half-pint chocolate fat free milk is recalled due to potential quality control issues. | — |
| 2025-12-10 | Class I | Africa ImportsH-0222-2026 | Product tested positive for Salmonella. | Environmental Monitoring |
| 2025-12-10 | Class II | Hale incH-0241-2026 | Potential to be contaminated with Clostridium botulinum. Products manufactured without an approved process filed. | Environmental Monitoring |
| 2025-12-10 | Class III | Avion Pharmaceuticals, LLCH-0233-2026 | Undeclared Soy. The firm received positive test results for soy which is not listed on the label. The firm also noticed that the amount of boron in the product is listed as 250mg per serving instead of 250mcg per serving. | Documentation & Change Control |
| 2025-12-10 | Class II | Great Lakes Cheese Co IncH-0218-2026 | Potential metal fragments from supplier raw material (downstream recall) | Environmental Monitoring |
| 2025-12-10 | Class I | Alanwar Food Corp.H-0234-2026 | Products found to contain leachable lead levels (0.323mg/L) | — |
| 2025-12-10 | Class II | Costco Wholesale CorporationH-0225-2026 | The 3oz. sealed packet of Caesar Dressing in Costco Chicken Sandwich w/ Caesar Salad may contain plastic material. | — |
| 2025-12-10 | Class I | Genepro Protein, Inc.H-0302-2026 | Product is mislabeled - the labeling contains incorrect ingredient information and fails to declare milk as an allergen | Documentation & Change Control |
| 2025-12-10 | Class II | Great Lakes Cheese Co IncH-0219-2026 | Potential metal fragments from supplier raw material (downstream recall) | Environmental Monitoring |
| 2025-12-03 | Class I | FRC INCH-0212-2026 | FDA environmental sample identified the presence of Listeria monocytogenes in the processing area where cheese was packaged. | Environmental Monitoring |
| 2025-12-03 | Class I | WFM Purchasing, LPH-0210-2026 | Twin Sisters Creamery's recall of cheese products due to WSDA testing that identified potential STEC and E. coli O103 contamination. Whole Foods Market received affected products through distributor Peterson Company and sold them by weight with store-generated labels. | Environmental Monitoring |
| 2025-12-03 | Class II | Jeni's Splendid Ice Creams LLCH-0207-2026 | Undeclared allergens - wheat and soy | Documentation & Change Control |
| 2025-12-03 | Class II | Nats Nuts LLCH-0206-2026 | Contains undeclared cashews | Documentation & Change Control |
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.