[ 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
2026-07-15Class IIMedline Industries, LPZ-2697-2026Convenience Kits contain Covidien Mon-a-Therm General Purpose Temperature Probes Size 9 Fr. Medtronic has issued a recall of specific production lots of the Covidien Mon-a-Therm general purpose temperature probe-size 9 due to an error in its distribution control process.Risk Management & CAPA
2026-07-15Class IIGasco Industrial Corp.D-0665-2026Subpotent drugValidation & Qualification
2026-07-15Class ILehi Valley Trading Company, IncH-1150-2026Undeclared Peanut. High Valley Orchard Chocolate Covered Raisins contains unintended undeclared peanut due to mis-packaging.Documentation & Change Control
2026-07-15Class IIEncore Medical, LPZ-2701-2026Due to packaging discrepancy with incorrect product size mixed up.Documentation & Change Control
2026-07-15Class IIEncore Medical, LPZ-2700-2026Due to packaging discrepancy with incorrect product size mixed up.Documentation & Change Control
2026-07-15Class ITrafa Pharmaceutical Inc.H-1144-2026Potential contamination with SalmonellaEnvironmental Monitoring
2026-07-15Class IIKlowen BracesZ-2699-2026A product error defect may cause incorrect bracket placement.Documentation & Change Control
2026-07-15Class IIWALLAC OYZ-2713-2026Reduction in the on-board stability of the GSP GALT assay. This may increase the likelihood of run-QC failures and consequently delay the reporting of patient results.Validation & Qualification
2026-07-15Class IIConvaTec, IncZ-2677-2026Surgical dressing manufactured out of specification (greater thickness).Validation & Qualification
2026-07-15Class IIIntegra LifeSciences Corp. (NeuroSciences)Z-2714-2026The current Omni-Tract Surgical Retractor System IFU states a dry time of 30 minutes. Integra LifeSciences has identified that the dry time needs to be extended to 90 minutes, 110 minutes, or 120 minutes depending on the sterilization cycle exposure time used.Environmental Monitoring
2026-07-15Class IIMedline Industries, LPZ-2696-2026Convenience Kits contain Covidien Mon-a-Therm General Purpose Temperature Probes Size 9 Fr. Medtronic has issued a recall of specific production lots of the Covidien Mon-a-Therm general purpose temperature probe-size 9 due to an error in its distribution control process.Risk Management & CAPA
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 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 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.