[ 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.
1,232 matching recalls
| Date | Class | Firm | Reason | Quality domain |
|---|---|---|---|---|
| 2026-01-14 | Class II | Fresh & Ready Foods LLCH-0354-2026 | Foreign material. | Environmental Monitoring |
| 2026-01-14 | Class I | GBC Food Services, LLCH-0381-2026 | Potential presence of Listeria monocytogenes. | Environmental Monitoring |
| 2026-01-14 | Class I | Ambriola Co., Inc., TheH-0371-2026 | Product tested positive for Listeria Monocytogenes. | Environmental Monitoring |
| 2026-01-14 | Class II | Fresh & Ready Foods LLCH-0353-2026 | Foreign material. | Environmental Monitoring |
| 2026-01-14 | Class II | MAYEJ COMERCIALIZADORA S. de R.L. de C.V.H-0392-2026 | pathogen Cyclospora cayetanensis | Environmental Monitoring |
| 2026-01-14 | Class I | Ambriola Co., Inc., TheH-0372-2026 | Product tested positive for Listeria Monocytogenes. | Environmental Monitoring |
| 2026-01-14 | Class I | Ambriola Co., Inc., TheH-0369-2026 | Product tested positive for Listeria Monocytogenes. | Environmental Monitoring |
| 2026-01-14 | Class II | Fresh & Ready Foods LLCH-0355-2026 | Foreign material. | Environmental Monitoring |
| 2026-01-14 | Class I | GBC Food Services, LLCH-0382-2026 | Potential presence of Listeria monocytogenes. | Environmental Monitoring |
| 2026-01-14 | Class I | Sam Dry Fruits and Nuts Enterprises, IncH-0357-2026 | Potential contamination with Salmonella. | Environmental Monitoring |
| 2026-01-14 | Class II | DIRECT SOURCE SEAFOOD LLCH-0380-2026 | Shrimp may be contaminated with Cesium-137 (Cs-137). | Environmental Monitoring |
| 2026-01-14 | Class I | Ambriola Co., Inc., TheH-0373-2026 | Product tested positive for Listeria Monocytogenes. | Environmental Monitoring |
| 2026-01-14 | Class II | Fresh & Ready Foods LLCH-0356-2026 | Foreign material. | Environmental Monitoring |
| 2026-01-14 | Class I | Ambriola Co., Inc., TheH-0367-2026 | Product tested positive for Listeria Monocytogenes. | Environmental Monitoring |
| 2026-01-14 | Class I | Ambriola Co., Inc., TheH-0370-2026 | Product tested positive for Listeria Monocytogenes. | Environmental Monitoring |
| 2026-01-14 | Class I | Ambriola Co., Inc., TheH-0368-2026 | Product tested positive for Listeria Monocytogenes. | Environmental Monitoring |
| 2026-01-14 | Class I | Ambriola Co., Inc., TheH-0374-2026 | Product tested positive for Listeria Monocytogenes. | Environmental Monitoring |
| 2026-01-14 | Class II | DIRECT SOURCE SEAFOOD LLCH-0379-2026 | Shrimp may be contaminated with Cesium-137 (Cs-137). | Environmental Monitoring |
| 2026-01-14 | Class I | Medinatura New Mexico, inc.D-0288-2026 | Microbial Contamination of Non-Sterile Products: The products have been found to contain yeast/mold and microbial contamination identified as Achromobacter. | Environmental Monitoring |
| 2026-01-14 | Class I | Medinatura New Mexico, inc.D-0289-2026 | Microbial Contamination of Non-Sterile Products: The products have been found to contain yeast/mold and microbial contamination identified as Achromobacter. | Environmental Monitoring |
| 2026-01-07 | Class II | INDIAN COOKWARE AND APPLIANCE LLCH-0349-2026 | Potential contamination due to leachable lead. | Environmental Monitoring |
| 2026-01-07 | Class II | Novo Nordisk Inc.D-0244-2026 | Presence of Particulate Matter: Hair was found in a prefilled syringe | Environmental Monitoring |
| 2026-01-07 | Class II | Tom Bumble LLCH-0391-2026 | Foreign material. | Environmental Monitoring |
| 2026-01-07 | Class II | Novo Nordisk Inc.D-0245-2026 | Presence of Particulate Matter: Hair was found in a prefilled syringe | Environmental Monitoring |
| 2025-12-31 | Class II | First & Last TavernH-0335-2026 | May be contaminated with Clostridium botulinum | 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.