[ 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 IIDabur India LimitedD-0637-2026CGMP Deviations; deficiencies observed during FDA inspectionRisk Management & CAPA
2026-06-24Class IARROW INTERNATIONAL, LLCZ-2365-2026Lidocaine, 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-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-2434-2026Kits 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 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 IIMedline Industries, LPZ-2419-2026Kits 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 IARROW INTERNATIONAL, LLCZ-2374-2026Lidocaine, 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 IAbiomed, Inc.Z-2360-2026Potential software error in the Automated Impella Controller ("AIC" ) when used in conjunction with left ventricular Impella devices.Data Integrity
2026-06-24Class IIMedline Industries, LPZ-2500-2026During 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 IIMedline Industries, LPZ-2497-2026During 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 IARROW INTERNATIONAL, LLCZ-2384-2026Lidocaine, 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 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 IARROW INTERNATIONAL, LLCZ-2368-2026Lidocaine, 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 IIMedline Industries, LPZ-2446-2026Kits 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-2416-2026Kits 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 IARROW INTERNATIONAL, LLCZ-2387-2026Lidocaine, 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 IIStaar Surgical AGZ-2509-2026Due to a software coding issues for calculating the implant orientation diagram printout for the implantation for toric implantable collamer lenses.—
2026-06-24Class IARROW INTERNATIONAL, LLCZ-2369-2026Lidocaine, 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 IARROW INTERNATIONAL, LLCZ-2396-2026Lidocaine, 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 IIHowmedica Osteonics Corp.Z-2462-2026Stryker has identified that Triathlon Universal Baseplate Size 3 (lot UZD9IB), is contained in packaging labeled as Triathlon Universal Baseplate Size 4 (lot TYX7OB), and Triathlon Universal Baseplate Size 4 (lot TYX7OB), is contained in packaging labeled as Triathlon Universal Baseplate Size 3, (lot UZD9IB).Documentation & Change Control
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.