[ 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 IIMasimo CorporationZ-2671-2026Two devices recalled: 1) Electrocardiogram (ECG) electrode assembly ECG feature may incorrectly detect extreme bradycardia, tachycardia and trigger alarms on normal heart rate patients, which may distract clinicians away from management of true positive alarms, which could delay treatment; 2) Small and medium size blood pressure cuffs may contain rough edges, may result in skin irritation/redness.Documentation & Change Control
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 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 IISiemens Medical Solutions USA, IncZ-2641-2026Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits.—
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 IIBoston Scientific CorporationZ-2634-2026Potential sterile breach of the pouches in which devices are packaged.Environmental 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 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 IIBard Access Systems, Inc.Z-2660-2026Due 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 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 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.