[ 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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315 matching recalls
DateClassFirmReasonQuality domain
2026-06-24Class IIMedline Industries, LPZ-2485-2026During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.Validation & Qualification
2026-06-24Class IIAccriva Diagnostics, Inc.Z-2460-2026Assayed Whole blood control contains labeling with incorrect performance range.Validation & Qualification
2026-06-24Class IIMedline Industries, LPZ-2505-2026During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.Validation & Qualification
2026-06-24Class IIMedline Industries, LPZ-2497-2026During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.Validation & Qualification
2026-06-24Class IIPAI Holdings LLCD-0592-2026Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023Validation & Qualification
2026-06-17Class IIPhilips North America LlcZ-2354-2026System was delivered without the required Seismic kit for Wall Stand VS2, which is designed to prevent damage and ensure stability of the Wall Stand VS2 during seismic events.Validation & Qualification
2026-06-17Class IIBERLIN HEART GMBHZ-2320-2026Blood pump inner package expiration date does not match the outer-correct expiration date, which may lead to delays in surgical procedures.Validation & Qualification
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
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 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
2026-06-10Class IIAdvanced Bionics, LLCZ-2283-2026Due to incorrect shelf-life expiration date.Validation & Qualification
2026-06-10Class IIBaxter Healthcare CorporationZ-2262-2026Affected lots may contain incorrect 0.8-micron filters. Use of a 0.8-micron filter in place of the validated 3-micron filter may lead to reduced flow efficiency, incomplete or slower transfers of ingredients, or system alarms. This issue may lead to clinical effects such as electrolyte imbalance, metabolic instability, delayed recovery, etc.Validation & Qualification
2026-06-10Class IIISato Pharmaceutical Inc.H-0892-2026Product does not meet label claim for Vitamin E.Validation & Qualification
2026-06-10Class IILannett Company Inc.D-0584-2026Failed Dissolution Specifications: during 12M LT stability testing OOS low for Stage 3 dissolution at the 24-hour timepoint.Validation & Qualification
2026-06-10Class IIAsclemed USA Inc.D-0555-2026CGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the FDA acceptable intake limit.Validation & Qualification
2026-06-10Class IIAscend Laboratories, LLCD-0556-2026Failed Dissolution Specifications: Olmesartan Medoxomil content below specificationsValidation & Qualification
2026-06-03Class IIIAbbVie Inc.D-0551-2026Failed Stability SpecificationsValidation & Qualification
2026-06-03Class IIIAVEVA Drug Delivery Systems, Inc.D-0550-2026Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of individual units.Validation & Qualification
2026-05-27Class IIPHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Z-2229-2026The deaeration hose in X-ray tube cooling units type CU3101, manufactured between February 2016 and May 2020, may degrade over time, potentially resulting in oil leakage. Oil leakage may affect the cooling performance of the X-ray tube. When the oil flow drops below a certain threshold, the system automatically switches to low-dose fluoroscopy and displays the message Low load fluoroscopy flavor selected: Tube cooler problem . This condition cannot be resolved by restarting the system.Validation & Qualification
2026-05-27Class IIISagent PharmaceuticalsD-0539-2026Failed Impurities/Degradation SpecificationsValidation & Qualification
2026-05-27Class IIIntegraDose Compounding Services LLCD-0548-2026Subpotent DrugValidation & Qualification
2026-05-27Class IIPHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Z-2228-2026The deaeration hose in X-ray tube cooling units type CU3101, manufactured between February 2016 and May 2020, may degrade over time, potentially resulting in oil leakage. Oil leakage may affect the cooling performance of the X-ray tube. When the oil flow drops below a certain threshold, the system automatically switches to low-dose fluoroscopy and displays the message Low load fluoroscopy flavor selected: Tube cooler problem . This condition cannot be resolved by restarting the system.Validation & Qualification
2026-05-27Class IIPHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Z-2227-2026The deaeration hose in X-ray tube cooling units type CU3101, manufactured between February 2016 and May 2020, may degrade over time, potentially resulting in oil leakage. Oil leakage may affect the cooling performance of the X-ray tube. When the oil flow drops below a certain threshold, the system automatically switches to low-dose fluoroscopy and displays the message Low load fluoroscopy flavor selected: Tube cooler problem . This condition cannot be resolved by restarting the system.Validation & 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.