[ 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 I | Albertsons Companies LLCH-0484-2025 | Potential contamination with Listeria monocytogenes. | Environmental Monitoring |
| 2025-08-20 | Class I | Reser's Fine Foods, Inc.H-0540-2025 | 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 | QST Ingredients and PackagingH-0496-2025 | Product may contain small metal fragments due to contaminated onion powder ingredient used in manufacturing. | Environmental Monitoring |
| 2025-08-20 | Class II | Tropicale Foods, LLCH-0467-2025 | Product label includes the ingredient CREAM but does not include Milk as the source. | Documentation & Change Control |
| 2025-08-20 | Class II | Jayone Foods, Inc.H-0500-2025 | Frozen Oyster product is potentially contaminated with Norovirus | Environmental Monitoring |
| 2025-08-20 | Class I | Albertsons Companies LLCH-0476-2025 | Potential contamination with Listeria monocytogenes. | Environmental Monitoring |
| 2025-08-20 | Class II | Tropicale Foods, LLCH-0462-2025 | Product label includes the ingredient CREAM but does not include Milk as the source. | Documentation & Change Control |
| 2025-08-20 | Class II | The Bonami Baking Company, Inc.H-0487-2025 | Undeclared milk from Contains statement. | Documentation & Change Control |
| 2025-08-20 | Class III | Enjoy Nutrition, LLC; dba Weyland Brain NutritionH-0443-2025 | Under potency / misbranding: product fails to meet labeled lithium orotate potency. (Downstream recall) from supplier of ingredient. | Validation & Qualification |
| 2025-08-20 | Class II | PAX Spices & Labs IncH-0457-2025 | Foreign object (metal) in granulated onion ingredient. | Environmental Monitoring |
| 2025-08-20 | Class II | Tropicale Foods, LLCH-0471-2025 | Product label includes the ingredient CREAM but does not include Milk as the source. | Documentation & Change Control |
| 2025-08-20 | Class II | AND GO CONCEPTS DBA SALAD AND GOH-0494-2025 | 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 III | Enjoy Nutrition, LLC; dba Weyland Brain NutritionH-0442-2025 | Under potency / misbranding: product fails to meet labeled lithium orotate potency. (Downstream recall) from supplier of ingredient. | Validation & Qualification |
| 2025-08-20 | Class II | Tropicale Foods, LLCH-0460-2025 | Product label includes the ingredient CREAM but does not include Milk as the source. | Documentation & Change Control |
| 2025-08-20 | Class I | Reser's Fine Foods, Inc.H-0543-2025 | 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 | Reser's Fine Foods, Inc.H-0539-2025 | 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 | Reser's Fine Foods, Inc.H-0545-2025 | Tuna Salad products are recalled due to potential contamination with Listeria monocytogenes because products containing Newly Weds Foods recalled Japanese Style Breadcrumbs. | Environmental Monitoring |
| 2025-08-13 | Class II | Dollar General CorporationH-0414-2025 | Temperature abuse due to temperature excursion in one shipping trailer | — |
| 2025-08-13 | Class I | Krasnyi Oktyabr USA IncH-0391-2025 | Clostridium botulinum (uneviscerated fish) | Environmental Monitoring |
| 2025-08-13 | Class II | Dollar General CorporationH-0412-2025 | Temperature abuse due to temperature excursion in one shipping trailer | — |
| 2025-08-13 | Class II | Dollar General CorporationH-0408-2025 | Temperature abuse due to temperature excursion in one shipping trailer | — |
| 2025-08-13 | Class II | Distinctive Foods LLCH-0456-2025 | Undeclared sesame. | Documentation & Change Control |
| 2025-08-13 | Class II | Dollar General CorporationH-0418-2025 | Temperature abuse due to temperature excursion in one shipping trailer | — |
| 2025-08-13 | Class II | Louisa Food Products, Inc.H-0389-2025 | Supplier recalled ingredient used in finished product for possible Listeria monocytogenes contamination | Environmental Monitoring |
| 2025-08-13 | Class II | Dollar General CorporationH-0416-2025 | Temperature abuse due to temperature excursion in one shipping trailer | — |
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.