[ 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 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.—
2026-06-17Class IIIRefresqueria Estrella Inc.H-0913-2026Undeclared FD&C Red 40Documentation & Change Control
2026-06-17Class IIGalaxy RG CorpH-0926-2026Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).Documentation & Change Control
2026-06-17Class IIGalaxy RG CorpH-0924-2026Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).Documentation & Change Control
2026-06-17Class IIGalaxy RG CorpH-0929-2026Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).Documentation & Change Control
2026-06-17Class IIGalaxy RG CorpH-0927-2026Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).Documentation & Change Control
2026-06-17Class IIGalaxy RG CorpH-0935-2026Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).Documentation & Change Control
2026-06-17Class ITotal Nutrition IncH-0942-2026Product may be contaminated with Salmonella.Environmental Monitoring
2026-06-17Class IIGalaxy RG CorpH-0920-2026Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).Documentation & Change Control
2026-06-17Class IIGalaxy RG CorpH-0919-2026Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).Documentation & Change Control
2026-06-17Class IIGalaxy RG CorpH-0932-2026Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).Documentation & Change Control
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 IIBreckenridge Pharmaceutical, Inc.D-0582-2026CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limitValidation & Qualification
2026-06-17Class IIIFresenius Kabi USA, LLCD-0581-2026Failed Impurities/Degradations SpecificationsValidation & Qualification
2026-06-17Class IIGolden State Medical Supply Inc.D-0587-2026Failed Dissolution Specifications: During 12-month long-term stability testing, subject lot was out of specification (low) for stage 3 dissolution at the 24-hour timepoint.Validation & Qualification
2026-06-17Class IIZep IncD-0586-2026Microbial contamination of sterile productsEnvironmental Monitoring
2026-06-17Class IISUN PHARMACEUTICAL INDUSTRIES INCD-0607-2026Presence of Foreign Substance:This recall has been initiated in response to a product quality complaint reported for black/brown specs and particles within the ampoule solution—
2026-06-17Class IBEEKEEPER'S NATURALS USA INC.D-0620-2026Microbial Contamination of Non-Sterile ProductsEnvironmental Monitoring
2026-06-17Class IIGalaxy RG CorpH-0936-2026Undeclared colors (Yellow #5, Yellow #6, and/or Red #40).Documentation & Change Control
2026-06-17Class IIAscend Laboratories, LLCD-0597-2026Failed Dissolution Specifications: An out-of-specification (OOS) result was observed during the 9th month of dissolution test analysisValidation & Qualification
2026-06-17Class IIBreckenridge Pharmaceutical, Inc.D-0583-2026CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limitValidation & Qualification
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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.