[ 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.

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1,232 matching recalls
DateClassFirmReasonQuality domain
2026-01-14Class IIFresh & Ready Foods LLCH-0354-2026Foreign material.Environmental Monitoring
2026-01-14Class IGBC Food Services, LLCH-0381-2026Potential presence of Listeria monocytogenes.Environmental Monitoring
2026-01-14Class IAmbriola Co., Inc., TheH-0371-2026Product tested positive for Listeria Monocytogenes.Environmental Monitoring
2026-01-14Class IIFresh & Ready Foods LLCH-0353-2026Foreign material.Environmental Monitoring
2026-01-14Class IIMAYEJ COMERCIALIZADORA S. de R.L. de C.V.H-0392-2026pathogen Cyclospora cayetanensisEnvironmental Monitoring
2026-01-14Class IAmbriola Co., Inc., TheH-0372-2026Product tested positive for Listeria Monocytogenes.Environmental Monitoring
2026-01-14Class IAmbriola Co., Inc., TheH-0369-2026Product tested positive for Listeria Monocytogenes.Environmental Monitoring
2026-01-14Class IIFresh & Ready Foods LLCH-0355-2026Foreign material.Environmental Monitoring
2026-01-14Class IGBC Food Services, LLCH-0382-2026Potential presence of Listeria monocytogenes.Environmental Monitoring
2026-01-14Class ISam Dry Fruits and Nuts Enterprises, IncH-0357-2026Potential contamination with Salmonella.Environmental Monitoring
2026-01-14Class IIDIRECT SOURCE SEAFOOD LLCH-0380-2026Shrimp may be contaminated with Cesium-137 (Cs-137).Environmental Monitoring
2026-01-14Class IAmbriola Co., Inc., TheH-0373-2026Product tested positive for Listeria Monocytogenes.Environmental Monitoring
2026-01-14Class IIFresh & Ready Foods LLCH-0356-2026Foreign material.Environmental Monitoring
2026-01-14Class IAmbriola Co., Inc., TheH-0367-2026Product tested positive for Listeria Monocytogenes.Environmental Monitoring
2026-01-14Class IAmbriola Co., Inc., TheH-0370-2026Product tested positive for Listeria Monocytogenes.Environmental Monitoring
2026-01-14Class IAmbriola Co., Inc., TheH-0368-2026Product tested positive for Listeria Monocytogenes.Environmental Monitoring
2026-01-14Class IAmbriola Co., Inc., TheH-0374-2026Product tested positive for Listeria Monocytogenes.Environmental Monitoring
2026-01-14Class IIDIRECT SOURCE SEAFOOD LLCH-0379-2026Shrimp may be contaminated with Cesium-137 (Cs-137).Environmental Monitoring
2026-01-14Class IMedinatura New Mexico, inc.D-0288-2026Microbial Contamination of Non-Sterile Products: The products have been found to contain yeast/mold and microbial contamination identified as Achromobacter.Environmental Monitoring
2026-01-14Class IMedinatura New Mexico, inc.D-0289-2026Microbial Contamination of Non-Sterile Products: The products have been found to contain yeast/mold and microbial contamination identified as Achromobacter.Environmental Monitoring
2026-01-07Class IIINDIAN COOKWARE AND APPLIANCE LLCH-0349-2026Potential contamination due to leachable lead.Environmental Monitoring
2026-01-07Class IINovo Nordisk Inc.D-0244-2026Presence of Particulate Matter: Hair was found in a prefilled syringeEnvironmental Monitoring
2026-01-07Class IITom Bumble LLCH-0391-2026Foreign material.Environmental Monitoring
2026-01-07Class IINovo Nordisk Inc.D-0245-2026Presence of Particulate Matter: Hair was found in a prefilled syringeEnvironmental Monitoring
2025-12-31Class IIFirst & Last TavernH-0335-2026May be contaminated with Clostridium botulinumEnvironmental Monitoring
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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.