[ 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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409 matching recalls
DateClassFirmReasonQuality domain
2026-06-24Class IIMedline Industries, LPZ-2436-2026Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.Risk Management & CAPA
2026-06-24Class IIDabur India LimitedD-0642-2026CGMP Deviations; deficiencies observed during FDA inspectionRisk Management & CAPA
2026-06-24Class IIMedline Industries, LPZ-2440-2026Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.Risk Management & CAPA
2026-06-24Class IIDabur India LimitedD-0629-2026CGMP Deviations; deficiencies observed during FDA inspectionRisk Management & CAPA
2026-06-24Class IIMedline Industries, LPZ-2420-2026Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.Risk Management & CAPA
2026-06-24Class IIDabur India LimitedD-0638-2026CGMP Deviations; deficiencies observed during FDA inspectionRisk Management & CAPA
2026-06-24Class IIDabur India LimitedD-0637-2026CGMP Deviations; deficiencies observed during FDA inspectionRisk Management & CAPA
2026-06-24Class IIMedline Industries, LPZ-2431-2026Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.Risk Management & CAPA
2026-06-24Class IIDabur India LimitedD-0632-2026CGMP Deviations; deficiencies observed during FDA inspectionRisk Management & CAPA
2026-06-24Class IIMedline Industries, LPZ-2427-2026Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.Risk Management & CAPA
2026-06-24Class IIMITO RED LIGHT INCZ-2478-2026The near-infrared therapy device contains a lithium-ion battery that may malfunction, causing it to catch fire or burst into flames.Risk Management & CAPA
2026-06-24Class IIMedline Industries, LPZ-2445-2026Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.Risk Management & CAPA
2026-06-24Class IIMedline Industries, LPZ-2437-2026Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.Risk Management & CAPA
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 IIMedline Industries, LPZ-2414-2026Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.Risk Management & CAPA
2026-06-24Class IIMedline Industries, LPZ-2432-2026Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.Risk Management & CAPA
2026-06-24Class IIDabur India LimitedD-0636-2026CGMP Deviations; deficiencies observed during FDA inspectionRisk Management & CAPA
2026-06-24Class IIMedline Industries, LPZ-2417-2026Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.Risk Management & CAPA
2026-06-24Class IIMedline Industries, LPZ-2429-2026Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.Risk Management & CAPA
2026-06-24Class IIDabur India LimitedD-0639-2026CGMP 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 IIDabur India LimitedD-0634-2026CGMP Deviations; deficiencies observed during FDA inspectionRisk Management & CAPA
2026-06-24Class IIMedline Industries, LPZ-2433-2026Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.Risk Management & CAPA
2026-06-24Class IIMedline Industries, LPZ-2444-2026Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.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.