[ 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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1,235 matching recalls
DateClassFirmReasonQuality domain
2026-03-18Class IMade Fresh Salads IncH-0559-2026Products may be contaminated with Listeria monocytogenes.Environmental Monitoring
2026-03-18Class IMade Fresh Salads IncH-0565-2026Products may be contaminated with Listeria monocytogenes.Environmental Monitoring
2026-03-18Class IMade Fresh Salads IncH-0558-2026Products may be contaminated with Listeria monocytogenes.Environmental Monitoring
2026-03-18Class IMade Fresh Salads IncH-0562-2026Products may be contaminated with Listeria monocytogenes.Environmental Monitoring
2026-03-18Class IMade Fresh Salads IncH-0555-2026Products may be contaminated with Listeria monocytogenes.Environmental Monitoring
2026-03-18Class IMade Fresh Salads IncH-0557-2026Products may be contaminated with Listeria monocytogenes.Environmental Monitoring
2026-03-18Class IIWillamette Valley Pie Company, LLCH-0550-2026Potential contamination with listeria monocytogenes.Environmental Monitoring
2026-03-18Class IMade Fresh Salads IncH-0563-2026Products may be contaminated with Listeria monocytogenes.Environmental Monitoring
2026-03-18Class IMade Fresh Salads IncH-0561-2026Products may be contaminated with Listeria monocytogenes.Environmental Monitoring
2026-03-18Class IMade Fresh Salads IncH-0566-2026Products may be contaminated with Listeria monocytogenes.Environmental Monitoring
2026-03-18Class IMade Fresh Salads IncH-0568-2026Products may be contaminated with Listeria monocytogenes.Environmental Monitoring
2026-03-11Class IIRadnostixD-0389-2026Presence of Particulate Matter: Due to production issuesEnvironmental Monitoring
2026-03-11Class IINew Life Pharma LLCD-0395-2026Lack of Assurance of SterilityEnvironmental Monitoring
2026-03-11Class IIHarbin Jixianglong Biotech Co., Ltd.D-0379-2026CGMP Deviations This recall has been initiated due to failing to complete process validation and bacterial endotoxin method validation before distributionEnvironmental Monitoring
2026-03-11Class IINew Life Pharma LLCD-0392-2026Lack of Assurance of SterilityEnvironmental Monitoring
2026-03-11Class IIIF Holding II, LLCH-0544-2026Potential contamination with patulin.Environmental Monitoring
2026-03-11Class IIItalianway Import, Inc.H-0540-2026Potential contamination with foreign material (Teflon fragments) from flaking cooking molds.Environmental Monitoring
2026-03-11Class IIHarbin Jixianglong Biotech Co., Ltd.D-0380-2026CGMP Deviations This recall has been initiated due to failing to complete process validation and bacterial endotoxin method validation before distributionEnvironmental Monitoring
2026-03-11Class IINew Life Pharma LLCD-0394-2026Lack of Assurance of SterilityEnvironmental Monitoring
2026-03-11Class IINew Life Pharma LLCD-0393-2026Lack of Assurance of SterilityEnvironmental Monitoring
2026-03-04Class IISLADE GORTON & CO., INC.H-0541-2026Contaminated with Listeria monocytogenesEnvironmental Monitoring
2026-03-04Class IILEO PHARMA INCD-0339-2026Lack of Assurance of Sterility: due to the presence of particulate matter in one unit from the lot, which lab tests have identified as wool fiber.Environmental Monitoring
2026-03-04Class IIGerber Products Company dba Nestle Infant NutritionH-0518-2026Downstream recall. Product contains arrowroot flour ingredient that was voluntarily recalled by the supplier due to potential contamination of soft kraft paper/plastic bag pieces.Environmental Monitoring
2026-03-04Class IIWizcure Pharmaa Private LimitedD-0351-2026Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.Environmental Monitoring
2026-03-04Class INavitas, LLC.H-0533-2026Potential contamination with Salmonella.Environmental 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.