[ 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
2026-05-13Class IIMedline Industries, LPZ-2099-2026Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.Environmental Monitoring
2026-05-13Class IIMedline Industries, LPZ-2100-2026Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.Environmental Monitoring
2026-05-13Class IIErbe Medical, LLCZ-2064-2026Devices providing sterile water/CO2/air to endoscopes were manufactured with a distal irrigation segment connector configuration that may be more susceptible to unintended water flow from distal tip under unsupported third-party connector use conditions, which may lead to water aspiration, which may progress to aspiration pneumonia, acute respiratory distress syndrome, or respiratory failure.Environmental Monitoring
2026-05-13Class IIIFalcon Trading Co., Inc.H-0695-2026Potential contamination with pesticides, haloxyfop and thiamethoxamEnvironmental Monitoring
2026-05-13Class IIITops Markets LLCH-0687-2026The potential contamination with Clostridium botulinum, due to risk of temperature abuse during chilled storage at the firmEnvironmental Monitoring
2026-05-13Class IGriffith Foods Inc.H-0693-2026Potential Salmonella contamination. The firm was notified from their supplier that the nonfat dry milk may be contaminated with Salmonella.Environmental Monitoring
2026-05-13Class IIITops Markets LLCH-0688-2026The potential contamination with Clostridium botulinum, due to risk of temperature abuse during chilled storage at the firmEnvironmental Monitoring
2026-05-13Class IIGreen Organic VegetablesH-0694-2026Foreign object: metal piecesEnvironmental Monitoring
2026-05-13Class IIWehah FarmsH-0767-2026Potential contamination with foreign materials.Environmental Monitoring
2026-05-13Class IGivaudan Flavors CorpH-0837-2026Product has the potential to be contaminated with Salmonella.Environmental Monitoring
2026-05-13Class IRaw Farm LLCH-0764-2026Multi-state outbreak of E. coli O157:H7.Environmental Monitoring
2026-05-13Class IGriffith Foods Inc.H-0691-2026Potential Salmonella contamination. The firm was notified from their supplier that the nonfat dry milk may be contaminated with Salmonella.Environmental Monitoring
2026-05-13Class IIIFalcon Trading Co., Inc.H-0696-2026Potential contamination with pesticides, haloxyfop and thiamethoxamEnvironmental Monitoring
2026-05-13Class IRaw Farm LLCH-0765-2026Multi-state outbreak of E. coli O157:H7.Environmental Monitoring
2026-05-13Class IIPost Consumer Brands, LLCH-0776-2026Foreign Material (plastic)Environmental Monitoring
2026-05-13Class IIFresenius Medical Care Holdings, Inc.D-0512-2026Lack of Assurance of Sterility: Potential leaks from perforations in bags.Environmental Monitoring
2026-05-13Class IIAcella Pharmaceuticals, LLCD-0523-2026Chemical contamination; presence of lead and lithium above specificationEnvironmental Monitoring
2026-05-13Class IGriffith Foods Inc.H-0692-2026Potential Salmonella contamination. The firm was notified from their supplier that the nonfat dry milk may be contaminated with Salmonella.Environmental Monitoring
2026-05-13Class IRaw Farm LLCH-0766-2026Multi-state outbreak of E. coli O157:H7.Environmental Monitoring
2026-05-13Class IRaw Farm LLCH-0763-2026Multi-state outbreak of E. coli O157:H7.Environmental Monitoring
2026-05-13Class ICalifornia Dairies Inc.H-0700-2026Potential contamination with Salmonella.Environmental Monitoring
2026-05-13Class IIMedline Industries, LPZ-2093-2026Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.Environmental Monitoring
2026-05-13Class IIMedline Industries, LPZ-2118-2026Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.Environmental Monitoring
2026-05-13Class IIMedline Industries, LPZ-2121-2026Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.Environmental Monitoring
2026-05-06Class IIAlcon Research LLCD-0491-2026Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.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.