[ 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.

Reset
409 matching recalls
DateClassFirmReasonQuality domain
2026-03-11Class IIACME UNITED CORPORATIOND-0368-2026CGMP DeviationsRisk Management & CAPA
2026-03-11Class IIACME UNITED CORPORATIOND-0376-2026CGMP DeviationsRisk Management & CAPA
2026-03-11Class IIACME UNITED CORPORATIOND-0366-2026CGMP DeviationsRisk Management & CAPA
2026-03-11Class IIACME UNITED CORPORATIOND-0362-2026CGMP DeviationsRisk Management & CAPA
2026-03-11Class IIACME UNITED CORPORATIOND-0375-2026CGMP DeviationsRisk Management & CAPA
2026-03-11Class IIACME UNITED CORPORATIOND-0373-2026CGMP DeviationsRisk Management & CAPA
2026-03-11Class IIACME UNITED CORPORATIOND-0369-2026CGMP DeviationsRisk Management & CAPA
2026-03-11Class IIACME UNITED CORPORATIOND-0358-2026CGMP DeviationsRisk Management & CAPA
2026-03-11Class IIACME UNITED CORPORATIOND-0367-2026CGMP DeviationsRisk Management & CAPA
2026-03-11Class IIACME UNITED CORPORATIOND-0364-2026CGMP DeviationsRisk Management & CAPA
2026-03-11Class IIACME UNITED CORPORATIOND-0361-2026CGMP DeviationsRisk Management & CAPA
2026-03-11Class IIACME UNITED CORPORATIOND-0360-2026CGMP DeviationsRisk Management & CAPA
2026-03-11Class IIACME UNITED CORPORATIOND-0365-2026CGMP DeviationsRisk Management & CAPA
2026-03-11Class IIACME UNITED CORPORATIOND-0371-2026CGMP DeviationsRisk Management & CAPA
2026-03-11Class IIACME UNITED CORPORATIOND-0374-2026CGMP DeviationsRisk Management & CAPA
2026-03-11Class IIACME UNITED CORPORATIOND-0370-2026CGMP DeviationsRisk Management & CAPA
2026-03-11Class IIACME UNITED CORPORATIOND-0372-2026CGMP DeviationsRisk Management & CAPA
2026-02-18Class IIPro Numb Tattoo Numbing Spray LLCD-0302-2026cGMP deviationsRisk Management & CAPA
2026-02-18Class IIPro Numb Tattoo Numbing Spray LLCD-0303-2026cGMP deviationsRisk Management & CAPA
2026-02-11Class IHANDELNINE GLOBAL LLCD-0332-2026CGMP Deviations: product found to contain lead.Risk Management & CAPA
2026-02-04Class IIWeaver's Brew LLCH-0438-2026Ginger Beer products might contain ginger juice that did not undergo the required pasteurization process.Risk Management & CAPA
2026-02-04Class IIWeaver's Brew LLCH-0435-2026Ginger Beer products might contain ginger juice that did not undergo the required pasteurization process.Risk Management & CAPA
2026-02-04Class IIWeaver's Brew LLCH-0436-2026Ginger Beer products might contain ginger juice that did not undergo the required pasteurization process.Risk Management & CAPA
2026-02-04Class IIWeaver's Brew LLCH-0437-2026Ginger Beer products might contain ginger juice that did not undergo the required pasteurization process.Risk Management & CAPA
2026-02-04Class IIWeaver's Brew LLCH-0439-2026Ginger Beer products might contain ginger juice that did not undergo the required pasteurization process.Risk Management & CAPA
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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.