[ 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 | QST Ingredients and PackagingH-0497-2025 | Product may contain small metal fragments due to contaminated onion powder ingredient used in manufacturing. | Environmental Monitoring |
| 2025-08-20 | Class II | Jagpreet Enterprises, LLC. dba Sukhi's Gourmet Indian FoodsH-0450-2025 | Potential contamination with foreign objects (metal pieces). | Environmental Monitoring |
| 2025-08-20 | Class III | Enjoy Nutrition, LLC; dba Weyland Brain NutritionH-0445-2025 | Under potency / misbranding: product fails to meet labeled lithium orotate potency. (Downstream recall) from supplier of ingredient. | Validation & Qualification |
| 2025-08-20 | Class II | The Bonami Baking Company, Inc.H-0488-2025 | Undeclared milk and soy (from soy lecithin) from sub-ingredients. | Documentation & Change Control |
| 2025-08-20 | Class II | QST Ingredients and PackagingH-0498-2025 | 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-0466-2025 | Product label includes the ingredient CREAM but does not include Milk as the source. | Documentation & Change Control |
| 2025-08-20 | Class II | Tropicale Foods, LLCH-0470-2025 | 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-0482-2025 | Potential contamination with Listeria monocytogenes. | Environmental Monitoring |
| 2025-08-20 | Class II | Tropicale Foods, LLCH-0461-2025 | Product label includes the ingredient CREAM but does not include Milk as the source. | Documentation & Change Control |
| 2025-08-20 | Class II | Tropicale Foods, LLCH-0468-2025 | 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-0483-2025 | Potential contamination with Listeria monocytogenes. | Environmental Monitoring |
| 2025-08-20 | Class II | The Bonami Baking Company, Inc.H-0489-2025 | Undeclared milk and/or eggs from sub-ingredients and/or Contains statement. | Documentation & Change Control |
| 2025-08-20 | Class I | Albertsons Companies LLCH-0486-2025 | Potential contamination with Listeria monocytogenes. | Environmental Monitoring |
| 2025-08-20 | Class I | Albertsons Companies LLCH-0475-2025 | Potential contamination with Listeria monocytogenes. | Environmental Monitoring |
| 2025-08-20 | Class I | Albertsons Companies LLCH-0478-2025 | Potential contamination with Listeria monocytogenes. | Environmental Monitoring |
| 2025-08-20 | Class II | Superior Foods CompanyH-0425-2025 | foreign material (plastic) | Environmental Monitoring |
| 2025-08-20 | Class II | The Bonami Baking Company, Inc.H-0491-2025 | Undeclared wheat, milk, and soy (from soy lecithin) from sub-ingredients. | Documentation & Change Control |
| 2025-08-20 | Class II | Jagpreet Enterprises, LLC. dba Sukhi's Gourmet Indian FoodsH-0451-2025 | Potential contamination with foreign objects (metal pieces). | Environmental Monitoring |
| 2025-08-20 | Class II | Tropicale Foods, LLCH-0459-2025 | Product label includes the ingredient CREAM but does not include Milk as the source. | Documentation & Change Control |
| 2025-08-20 | Class II | Jagpreet Enterprises, LLC. dba Sukhi's Gourmet Indian FoodsH-0449-2025 | Potential contamination with foreign objects (metal pieces). | Environmental Monitoring |
| 2025-08-20 | Class I | Albertsons Companies LLCH-0477-2025 | Potential contamination with Listeria monocytogenes. | Environmental Monitoring |
| 2025-08-20 | Class III | GMP Laboratories of America IncH-0447-2025 | Downstream recall of a dietary supplement ingredient that was manufactured out of specifications. | Validation & Qualification |
| 2025-08-20 | Class III | Enjoy Nutrition, LLC; dba Weyland Brain NutritionH-0446-2025 | 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-0464-2025 | 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-0492-2025 | The firm manufactured and distributed to retailers unpasteurized juice products in violation of 21 CFR 120 Juice HACCP regulations | Risk Management & CAPA |
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.