[ 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
214
Class I (most serious)
167
Drug
520
Device
313
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 |
|---|---|---|---|---|
| 2025-08-20 | Class II | AND GO CONCEPTS DBA SALAD AND GOH-0493-2025 | The firm manufactured and distributed to retailers unpasteurized juice products in violation of 21 CFR 120 Juice HACCP regulations | Risk Management & CAPA |
| 2025-08-20 | Class II | Tropicale Foods, LLCH-0465-2025 | Product label includes the ingredient CREAM but does not include Milk as the source. | Documentation & Change Control |
| 2025-08-20 | Class I | Albertsons Companies LLCH-0473-2025 | Potential contamination with Listeria monocytogenes. | Environmental Monitoring |
| 2025-08-20 | Class III | Enjoy Nutrition, LLC; dba Weyland Brain NutritionH-0444-2025 | Under potency / misbranding: product fails to meet labeled lithium orotate potency. (Downstream recall) from supplier of ingredient. | Validation & Qualification |
| 2025-08-20 | Class I | Reser's Fine Foods, Inc.H-0541-2025 | Tuna Salad products are recalled due to potential contamination with Listeria monocytogenes because products containing Newly Weds Foods recalled Japanese Style Breadcrumbs. | Environmental Monitoring |
| 2025-08-20 | Class I | Albertsons Companies LLCH-0480-2025 | Potential contamination with Listeria monocytogenes. | Environmental Monitoring |
| 2025-08-20 | Class I | Albertsons Companies LLCH-0479-2025 | Potential contamination with Listeria monocytogenes. | Environmental Monitoring |
| 2025-08-20 | Class II | Tropicale Foods, LLCH-0463-2025 | Product label includes the ingredient CREAM but does not include Milk as the source. | Documentation & Change Control |
| 2025-08-20 | Class I | Albertsons Companies LLCH-0472-2025 | Potential contamination with Listeria monocytogenes. | Environmental Monitoring |
| 2025-08-20 | Class I | Reser's Fine Foods, Inc.H-0542-2025 | Tuna Salad products are recalled due to potential contamination with Listeria monocytogenes because products containing Newly Weds Foods recalled Japanese Style Breadcrumbs. | Environmental Monitoring |
| 2025-08-20 | Class II | Jagpreet Enterprises, LLC. dba Sukhi's Gourmet Indian FoodsH-0452-2025 | Potential contamination with foreign objects (metal pieces). | Environmental Monitoring |
| 2025-08-20 | Class I | Quesito El EstabloH-0536-2025 | Product was manufactured and held under insanitary conditions. Product may be contaminated with Listeria monocytogenes. | Environmental Monitoring |
| 2025-08-20 | Class II | Tropicale Foods, LLCH-0469-2025 | Product label includes the ingredient CREAM but does not include Milk as the source. | Documentation & Change Control |
| 2025-08-20 | Class I | Albertsons Companies LLCH-0485-2025 | Potential contamination with Listeria monocytogenes. | Environmental Monitoring |
| 2025-08-20 | Class II | QST Ingredients and PackagingH-0495-2025 | Product may contain small metal fragments due to contaminated onion powder ingredient used in manufacturing. | Environmental Monitoring |
| 2025-08-20 | Class III | Shang Hao Jia, IncH-0455-2025 | Various snack cracker products are mislabeled and do not declare all allergen ingredients (Whole Milk Powder and wheat). | Documentation & Change Control |
| 2025-08-20 | Class II | Jayone Foods, Inc.H-0501-2025 | Frozen Oyster product is potentially contaminated with Norovirus | Environmental Monitoring |
| 2025-08-20 | Class I | Reser's Fine Foods, Inc.H-0544-2025 | Tuna Salad products are recalled due to potential contamination with Listeria monocytogenes because products containing Newly Weds Foods recalled Japanese Style Breadcrumbs. | Environmental Monitoring |
| 2025-08-20 | Class III | Aceto US, L.L.CH-0441-2025 | 4% Lithium Orotate product may only contain 3% and 9% Lithium Orotate product may contain 4.45% | — |
| 2025-08-20 | Class III | GMP Laboratories of America IncH-0448-2025 | Downstream recall of a dietary supplement ingredient that was manufactured out of specification. | Validation & Qualification |
| 2025-08-20 | Class III | Shang Hao Jia, IncH-0454-2025 | Various snack cracker products are mislabeled and do not declare all allergen ingredients (Whole Milk Powder and wheat). | Documentation & Change Control |
| 2025-08-20 | Class I | Albertsons Companies LLCH-0474-2025 | Potential contamination with Listeria monocytogenes. | Environmental Monitoring |
| 2025-08-20 | Class II | The Bonami Baking Company, Inc.H-0490-2025 | Undeclared wheat and milk from sub-ingredients. | Documentation & Change Control |
| 2025-08-20 | Class III | Shang Hao Jia, IncH-0453-2025 | Various snack cracker products are mislabeled and do not declare all allergen ingredients (Whole Milk Powder and wheat). | Documentation & Change Control |
| 2025-08-20 | Class II | Dollar General CorporationH-0499-2025 | Potential presence of glass pieces | — |
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.