[ 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 |
|---|---|---|---|---|
| 2025-12-31 | Class II | A New Life Herbs, LLCH-0342-2026 | Unapproved drug claims on product labeling and product misbranded due to no Supplement Facts label | Documentation & Change Control |
| 2025-12-31 | Class II | A New Life Herbs, LLCH-0341-2026 | Unapproved drug claims on product labeling and product misbranded due to no Supplement Facts label | Documentation & Change Control |
| 2025-12-31 | Class II | A New Life Herbs, LLCH-0344-2026 | Unapproved drug claims on product labeling and product misbranded due to no Supplement Facts label | Documentation & Change Control |
| 2025-12-31 | Class II | A New Life Herbs, LLCH-0346-2026 | Unapproved drug claims on product labeling and product misbranded due to no Supplement Facts label | Documentation & Change Control |
| 2025-12-31 | Class I | Mellace Family Brands California IncH-0337-2026 | Potential contamination with Salmonella | Environmental Monitoring |
| 2025-12-24 | Class II | CELEBRATION HERBALS USH-0328-2026 | possible salmonella | Environmental Monitoring |
| 2025-12-24 | Class I | The Whole Herb Company, Inc.H-0325-2026 | Potential contamination with Salmonella. | Environmental Monitoring |
| 2025-12-24 | Class II | The New York Milk Bank, Inc.H-0308-2026 | Foreign object | Environmental Monitoring |
| 2025-12-24 | Class I | MAMTAKIM, Inc.H-0312-2026 | Clostridium botulinum (uneviscerated fish) | Environmental Monitoring |
| 2025-12-24 | Class I | Lexunder IncH-0309-2026 | Contaminated with Salmonella | Environmental Monitoring |
| 2025-12-24 | Class I | MAMTAKIM, Inc.H-0311-2026 | Clostridium botulinum (uneviscerated fish) | Environmental Monitoring |
| 2025-12-24 | Class II | Good Way Trading Group IncH-0313-2026 | contains high levels of lead (10.7 mg/kg) | — |
| 2025-12-24 | Class II | Shata Traders Inc.H-0306-2026 | Products found to contain leachable lead levels (3.00 mg/L) | — |
| 2025-12-24 | Class I | Lexunder IncH-0310-2026 | Contaminated with Salmonella | Environmental Monitoring |
| 2025-12-24 | Class II | Hollandia Dairy, Inc.H-0307-2026 | 100% Appleberry Juice contaminated with cleaning solution, Peracetic Acid. | Environmental Monitoring |
| 2025-12-24 | Class II | Dough-To-Go IncH-0364-2026 | Undeclared Milk and FD&C Blue #1. | Documentation & Change Control |
| 2025-12-17 | Class I | CHETAK NEW YORK LLCH-0278-2026 | Product tested positive Salmonella . | Environmental Monitoring |
| 2025-12-17 | Class II | Prairie Farms DairyH-0305-2026 | Product may contain food-grade cleaning agents | — |
| 2025-12-17 | Class I | Moonlight Packing CorporationH-0314-2026 | Potential contamination with Listeria monocytogenes. | Environmental Monitoring |
| 2025-12-17 | Class II | India's Fine Foods, Inc.H-0242-2026 | Potential contamination due to leachable lead. | Environmental Monitoring |
| 2025-12-17 | Class I | CHETAK NEW YORK LLCH-0254-2026 | Product tested positive Salmonella . | Environmental Monitoring |
| 2025-12-17 | Class I | CHETAK NEW YORK LLCH-0298-2026 | Product tested positive Salmonella . | Environmental Monitoring |
| 2025-12-17 | Class I | CHETAK NEW YORK LLCH-0256-2026 | Product tested positive Salmonella . | Environmental Monitoring |
| 2025-12-17 | Class I | CHETAK NEW YORK LLCH-0258-2026 | Product tested positive Salmonella . | Environmental Monitoring |
| 2025-12-17 | Class I | CHETAK NEW YORK LLCH-0287-2026 | Product tested positive Salmonella . | 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.