[ 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 IIACCORD HEALTHCARE, INC.D-0656-2026Subpotent DrugValidation & Qualification
2026-07-08Class IIMedline Industries, LPZ-2612-2026Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on these catheters. This has led to instances of leakage, lumen damage, and breakage, and may lead to infection, medication loss, and/or blood loss.Risk Management & CAPA
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 IIBoston Scientific CorporationZ-2630-2026Potential sterile breach of the pouches in which devices are packaged.Environmental Monitoring
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 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 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 IIBaxter Healthcare CorporationZ-2638-2026The Adapter for Head Positioning accessory may become loose during patient positioning and unintentionally move when used in conjunction with the side rails of the Upper Back Section H V U component on Baxter operating tables.—
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 IWindstone Medical Packaging, Inc.Z-2622-2026Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.Environmental Monitoring
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 IWindstone Medical Packaging, Inc.Z-2620-2026Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.Environmental Monitoring
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 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.