[ 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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1,235 matching recalls
DateClassFirmReasonQuality domain
2026-06-24Class IARROW INTERNATIONAL, LLCZ-2373-2026Lidocaine, 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-2390-2026Lidocaine, 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-2394-2026Lidocaine, 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 IGREENWORLD FOOD EXPRESS (USA) LLCH-0950-2026Product may be contaminated with SalmonellaEnvironmental Monitoring
2026-06-24Class IIInternational Food Products CorporationH-1078-2026Potential for SalmonellaEnvironmental Monitoring
2026-06-24Class IARROW INTERNATIONAL, LLCZ-2372-2026Lidocaine, 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-2379-2026Lidocaine, 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-2367-2026Lidocaine, 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-2385-2026Lidocaine, 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-2370-2026Lidocaine, 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-2381-2026Lidocaine, 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 IIInternational Food Products CorporationH-1076-2026Product tested positive for SalmonellaEnvironmental Monitoring
2026-06-24Class IARROW INTERNATIONAL, LLCZ-2391-2026Lidocaine, 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-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 IARROW INTERNATIONAL, LLCZ-2375-2026Lidocaine, 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-2382-2026Lidocaine, 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-2395-2026Lidocaine, 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
2026-06-17Class IIIAmneal Pharmaceuticals, LLCD-0585-2026Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer.Environmental Monitoring
2026-06-17Class ISUN PHARMACEUTICAL INDUSTRIES INCD-0580-2026Presence of Particulate matter: Particulate matter identified as glass.Environmental Monitoring
2026-06-17Class IHaleon US Holdings LLCD-0595-2026Chemical Contamination: contamination with a diluted propylene glycol-based coolant from a machine leakage during the packaging process.Environmental Monitoring
2026-06-17Class IIU.S. Tov, Inc. dba U.S. Trading CompanyH-0943-2026Potential contamination with lead.Environmental Monitoring
2026-06-17Class IIIMothers' Milk Bank of Louisiana at Ochsner BaptistH-0938-2026Potential physical contamination: dark spot was noticed on the bottom of container.Environmental Monitoring
2026-06-17Class IIZep IncD-0586-2026Microbial contamination of sterile productsEnvironmental Monitoring
2026-06-17Class IBEEKEEPER'S NATURALS USA INC.D-0620-2026Microbial Contamination of Non-Sterile ProductsEnvironmental Monitoring
2026-06-17Class IHH FRESH TRADING CORPH-0939-2026Imported Enoki Mushrooms tested positive for Listeria Monocytogenes.Environmental Monitoring
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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.