[ 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-2424-2026Kits 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-2441-2026Kits 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-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 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-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-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-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-2435-2026Kits 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 IISmith & Nephew, Inc.Z-2456-2026Humeral nail due to a manufacturing error is missing distal holes and if implanted may lead to revision surgery but, if the missing holes are identified before implantation, an equivalent backup can be used, or a bent nail of the same size, which would require additional surgical steps to address soft tissue/bone preparation, which could lead to a surgical delay of greater than 30 minutes.Risk Management & CAPA
2026-06-24Class IIMedline Industries, LPZ-2423-2026Kits 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-2426-2026Kits 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-2443-2026Kits 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 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-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-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
2026-06-24Class IIMedline Industries, LPZ-2439-2026Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.Risk Management & CAPA
2026-06-17Class IIElekta, Inc.Z-2406-2026Software may fail to load adapted baseline shift plan during treatment delivery when a communication error occurs.Risk Management & CAPA
2026-06-10Class IB Braun Medical IncZ-2277-2026These procedure kits contain Bupivacaine Hydrochloride in Dextrose Injection, USP. The manufacturer of the Bupivacaine, Huons Co, Ltd., has issued a voluntary recall due to potential quality issues identified during a recent FDA manufacturing facility inspection.Risk Management & CAPA
2026-06-10Class IBecton Dickinson & CompanyZ-2251-2026This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing.Risk Management & CAPA
2026-06-10Class IBecton Dickinson & CompanyZ-2253-2026This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing.Risk Management & CAPA
2026-06-10Class IBecton Dickinson & CompanyZ-2250-2026This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing.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.