[ 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
2026-07-15Class 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 IIGasco Industrial Corp.D-0666-2026Subpotent drugValidation & Qualification
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 IIBlaine Labs IncD-0698-2026CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiryValidation & Qualification
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-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 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 IIACCORD HEALTHCARE, INC.D-0656-2026Subpotent DrugValidation & Qualification
2026-07-08Class IIMentor Texas LPZ-2614-2026A single lot of expired syringes were distributed due to a distribution system control failure.Validation & Qualification
2026-07-08Class IHamilton Medical AGZ-2463-2026Ventilator coaxial breathing circuit may have, expiratory valve sets with membranes sticking to valve body, not detectable during pre-operative test, which will result in "exhalation obstructed " alarm, which may result in inadequate ventilation, oxygen desaturation. Advising: Prior to use, test lung action. If alarm occurs, expiratory valve set removal to overcome membrane adhesion or replacementValidation & Qualification
2026-07-08Class IIBlaine Labs IncD-0697-2026CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiryValidation & Qualification
2026-07-01Class IIDirect RxD-0617-2026CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limitValidation & Qualification
2026-07-01Class IIElevate Oral CareD-0627-2026sub potencyValidation & Qualification
2026-07-01Class IIThe Harvard Drug Group LLCD-0609-2026Subpotent DrugValidation & Qualification
2026-06-24Class IIPAI Holdings LLCD-0591-2026Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023Validation & Qualification
2026-06-24Class IIGlenmark Pharmaceuticals Inc., USAD-0588-2026Failed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification results total impurities.Validation & Qualification
2026-06-24Class IIPAI Holdings LLCD-0590-2026Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023Validation & Qualification
2026-06-24Class IIPAI Holdings LLCD-0589-2026Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023Validation & Qualification
2026-06-24Class IIMedline Industries, LPZ-2489-2026During 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 IIIntegraDose Compounding Services LLCD-0593-2026Subpotent DrugValidation & Qualification
2026-06-24Class IIInventia Healthcare LimitedD-0610-2026Failed Dissolution SpecificationsValidation & Qualification
2026-06-24Class IIMedline Industries, LPZ-2499-2026During 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-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 IIMedline Industries, LPZ-2484-2026During 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
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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.