[ 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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3,493 matching recalls
DateClassFirmReasonQuality domain
2026-06-24Class IARROW INTERNATIONAL, LLCZ-2392-2026Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.Environmental Monitoring
2026-06-24Class IIDabur India LimitedD-0642-2026CGMP Deviations; deficiencies observed during FDA inspectionRisk Management & CAPA
2026-06-24Class IIISandoz IncD-0608-2026Labeling: Incorrect or Missing Lot and/or Exp DateDocumentation & Change Control
2026-06-24Class IIDabur India LimitedD-0638-2026CGMP Deviations; deficiencies observed during FDA inspectionRisk Management & CAPA
2026-06-24Class IIInternational Food Products CorporationH-1077-2026Potential for SalmonellaEnvironmental Monitoring
2026-06-24Class IIDabur India LimitedD-0632-2026CGMP Deviations; deficiencies observed during FDA inspectionRisk Management & CAPA
2026-06-24Class IIAjanta Pharma USA IncD-0594-2026Product Mix-Up: A bottle containing Voriconazole Tablets 50 mg was labelled and distributed as Aripiprazole Tablets USP 30 mg.Documentation & Change Control
2026-06-24Class IIPAI Holdings LLCD-0589-2026Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023Validation & Qualification
2026-06-24Class IIPAI Holdings LLCD-0591-2026Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023Validation & Qualification
2026-06-24Class IIPAI Holdings LLCD-0590-2026Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023Validation & Qualification
2026-06-24Class IIDabur India LimitedD-0636-2026CGMP Deviations; deficiencies observed during FDA inspectionRisk Management & CAPA
2026-06-24Class IIDabur India LimitedD-0639-2026CGMP Deviations; deficiencies observed during FDA inspectionRisk Management & CAPA
2026-06-24Class IIInternational Food Products CorporationH-1078-2026Potential for SalmonellaEnvironmental Monitoring
2026-06-24Class IIDabur India LimitedD-0629-2026CGMP Deviations; deficiencies observed during FDA inspectionRisk Management & CAPA
2026-06-24Class IIIntegraDose Compounding Services LLCD-0593-2026Subpotent DrugValidation & Qualification
2026-06-24Class IIDabur India LimitedD-0637-2026CGMP Deviations; deficiencies observed during FDA inspectionRisk Management & CAPA
2026-06-24Class IIMedline Industries, LPZ-2485-2026During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.Validation & Qualification
2026-06-24Class IIDabur India LimitedD-0630-2026CGMP Deviations; deficiencies observed during FDA inspectionRisk Management & CAPA
2026-06-24Class IIDabur India LimitedD-0641-2026CGMP Deviations; deficiencies observed during FDA inspectionRisk Management & CAPA
2026-06-24Class IIDabur India LimitedD-0640-2026CGMP Deviations; deficiencies observed during FDA inspectionRisk Management & CAPA
2026-06-24Class IIMedline Industries, LPZ-2482-2026During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.Validation & Qualification
2026-06-24Class IIKeystone IndustriesD-0602-2026Defective container:may contain bottles with incomplete seals—
2026-06-24Class IIDabur India LimitedD-0633-2026CGMP Deviations; deficiencies observed during FDA inspectionRisk Management & CAPA
2026-06-24Class IIGlenmark Pharmaceuticals Inc., USAD-0588-2026Failed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification results total impurities.Validation & Qualification
2026-06-24Class IIKeystone IndustriesD-0605-2026Defective container:may contain bottles with incomplete seals—
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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.