[ 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
2026-03-04Class IIWizcure Pharmaa Private LimitedD-0346-2026Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.Environmental Monitoring
2026-03-04Class IIWizcure Pharmaa Private LimitedD-0347-2026Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.Environmental Monitoring
2026-03-04Class IIWizcure Pharmaa Private LimitedD-0349-2026Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.Environmental Monitoring
2026-03-04Class IOregon Potato Company LLCH-0522-2026Listeria monocytogenesEnvironmental Monitoring
2026-03-04Class IIWizcure Pharmaa Private LimitedD-0350-2026Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.Environmental Monitoring
2026-03-04Class IIWizcure Pharmaa Private LimitedD-0348-2026Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.Environmental Monitoring
2026-03-04Class IIWizcure Pharmaa Private LimitedD-0352-2026Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.Environmental Monitoring
2026-02-25Class IILotus Mom Corporation dba Indian Kitchen MartH-0511-2026Potential contamination with leachable lead.Environmental Monitoring
2026-02-25Class ILotus Mom Corporation dba Indian Kitchen MartH-0514-2026Potential contamination with leachable lead.Environmental Monitoring
2026-02-25Class IILotus Mom Corporation dba Indian Kitchen MartH-0512-2026Potential contamination with leachable lead.Environmental Monitoring
2026-02-25Class IIWoodland Foods LLCH-0515-2026Possible presence of Foreign MaterialEnvironmental Monitoring
2026-02-25Class IILotus Mom Corporation dba Indian Kitchen MartH-0513-2026Potential contamination with leachable lead.Environmental Monitoring
2026-02-25Class IArt Monkey LLC dba Why Not NaturalH-0510-2026Potential to be contaminated with SalmonellaEnvironmental Monitoring
2026-02-25Class IIH & N Group Inc.H-0516-2026Product manufactured under insanitary conditions whereby it may have been contaminated with Cesium-137 (Cs-137)Environmental Monitoring
2026-02-18Class IIF.H. INVESTMENTS, Inc. (dba Asteria Health)D-0324-2026Presence of Foreign substance - potential presence of metal particulate matterEnvironmental Monitoring
2026-02-18Class IIF.H. INVESTMENTS, Inc. (dba Asteria Health)D-0325-2026Presence of Foreign substance - potential presence of metal particulate matterEnvironmental Monitoring
2026-02-18Class IIF.H. INVESTMENTS, Inc. (dba Asteria Health)D-0314-2026Presence of Foreign substance - potential presence of metal particulate matterEnvironmental Monitoring
2026-02-18Class IIF.H. INVESTMENTS, Inc. (dba Asteria Health)D-0317-2026Presence of Foreign substance - potential presence of metal particulate matterEnvironmental Monitoring
2026-02-18Class IIF.H. INVESTMENTS, Inc. (dba Asteria Health)D-0331-2026Presence of Foreign substance - potential presence of metal particulate matterEnvironmental Monitoring
2026-02-18Class IIF.H. INVESTMENTS, Inc. (dba Asteria Health)D-0326-2026Presence of Foreign substance - potential presence of metal particulate matterEnvironmental Monitoring
2026-02-18Class IIF.H. INVESTMENTS, Inc. (dba Asteria Health)D-0313-2026Presence of Foreign substance - potential presence of metal particulate matterEnvironmental Monitoring
2026-02-18Class IIF.H. INVESTMENTS, Inc. (dba Asteria Health)D-0308-2026Presence of Foreign substance - potential presence of metal particulate matterEnvironmental Monitoring
2026-02-18Class IIFresenius Kabi Compounding, LLCD-0335-2026Lack of Assurance of SterilityEnvironmental Monitoring
2026-02-18Class IIF.H. INVESTMENTS, Inc. (dba Asteria Health)D-0323-2026Presence of Foreign substance - potential presence of metal particulate matterEnvironmental Monitoring
2026-02-18Class IIF.H. INVESTMENTS, Inc. (dba Asteria Health)D-0315-2026Presence of Foreign substance - potential presence of metal particulate matterEnvironmental 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.