[ 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
2026-07-08Class IICareFusion 213, LLCD-0644-2026Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channelEnvironmental Monitoring
2026-07-08Class IIACCORD HEALTHCARE, INC.D-0656-2026Subpotent DrugValidation & Qualification
2026-07-08Class IIMcKessonD-0714-2026Temperature Abuse: Product was stored incorrectly in a controlled room temperature environment instead of a refrigerated environment.Documentation & Change Control
2026-07-08Class IICareFusion 213, LLCD-0650-2026Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channelEnvironmental Monitoring
2026-07-08Class IIBlaine Labs IncD-0695-2026CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiryValidation & Qualification
2026-07-08Class IIBlaine Labs IncD-0693-2026CGMP Deviations: product manufactured in the same facility under the same conditions as the product found to be contaminatedEnvironmental Monitoring
2026-07-08Class IIBard Access Systems, Inc.Z-2656-2026Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.Risk Management & CAPA
2026-07-08Class IIBlaine Labs IncD-0699-2026CGMP Deviations; product manufactured in the same facility under the same conditions as the product found to be contaminatedEnvironmental Monitoring
2026-07-08Class IIBlaine Labs IncD-0696-2026CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiryValidation & Qualification
2026-07-08Class IILupin Pharmaceuticals Inc.D-0655-2026Presence of Foreign Substance—
2026-07-08Class IIRemel, IncZ-2623-2026Reduced or no recovery of some strains of Neisseria gonorrhoeae.—
2026-07-08Class IICareFusion 213, LLCD-0651-2026Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channelEnvironmental Monitoring
2026-07-08Class IIBlaine Labs IncD-0694-2026CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiryValidation & Qualification
2026-07-08Class IIISUN PHARMACEUTICAL INDUSTRIES INCD-0654-2026Failed Impurities/Degradation SpecificationsValidation & Qualification
2026-07-08Class IIMedline Industries, LPZ-2542-2026The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site.Risk Management & CAPA
2026-07-08Class IBlaine Labs IncD-0692-2026Microbial contamination of Non-Sterile Product: samples identified the presence of Lysinibacillus fusiformis and other Bacillus sppEnvironmental Monitoring
2026-07-08Class IICareFusion 213, LLCD-0652-2026Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channelEnvironmental Monitoring
2026-07-08Class IILupin Pharmaceuticals Inc.D-0723-2026CGMP deviation: OOS result observed for the Gliding Force functionality test during 12-month long term stability testing.Validation & Qualification
2026-07-08Class IIBlaine Labs IncD-0698-2026CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiryValidation & Qualification
2026-07-08Class IIAsclemed USA Inc.D-0658-2026Lack of Assurance of SterilityEnvironmental Monitoring
2026-07-08Class IICipla USA, Inc.D-0661-2026cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).Risk Management & CAPA
2026-07-08Class IIBlaine Labs IncD-0697-2026CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiryValidation & Qualification
2026-07-08Class IIBard Access Systems, Inc.Z-2662-2026Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.Risk Management & CAPA
2026-07-08Class IICareFusion 213, LLCD-0643-2026Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channelEnvironmental Monitoring
2026-07-08Class IICareFusion 213, LLCD-0646-2026Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channelEnvironmental 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.