[ 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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758 matching recalls
DateClassFirmReasonQuality domain
2026-04-29Class IIMedline Industries, LPZ-1889-2026Unapproved design changes to the products outside of the 510(k) clearance.Documentation & Change Control
2026-04-29Class IIMedline Industries, LPZ-1842-2026The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.Documentation & Change Control
2026-04-22Class IINephron SC, LLCD-0479-2026Labelling: Illegible labelDocumentation & Change Control
2026-04-22Class IILinkbio Corp.Z-1810-2026The CORE Workstation may display an incorrect "Planning Date " when viewing cases on the "Start Case" menu screen.Documentation & Change Control
2026-04-22Class IIPURE PALM C/O DVDH-0681-2026mislabeled Coconut Date Bites. (product is coconut covered, label is for regular date bites)Documentation & Change Control
2026-04-15Class IIBlueroot Health, Inc.H-0663-2026Contains undeclared egg, soy, and hazelnutDocumentation & Change Control
2026-04-15Class IIBeckman Coulter, Inc.Z-1794-2026Due to manufacturing issue (incorrectly processing) with in vitro multidrug resistant test.Documentation & Change Control
2026-04-15Class IIRiverence Provisions LLCH-0662-2026Label declares cream cheese but does not declare milkDocumentation & Change Control
2026-04-15Class IITeva Pharmaceuticals USA, IncD-0473-2026CGMP Deviations: use of an unapproved raw materialDocumentation & Change Control
2026-04-15Class IIXTANT Medical Holdings, IncZ-1773-2026Units from one lot were mislabeled with an incorrect part number, identifying the device as a shorter screw length than it physically is.Documentation & Change Control
2026-04-15Class IIF&S Fresh Foods, Inc.H-0659-2026Undeclared sesame. Sandwich contains visible sesame but label does not declare sesame.Documentation & Change Control
2026-04-15Class IPure Vitamins and Natural Supplements, LLCH-0653-2026FDA analysis revealed the presence of undeclared sildenafil and TadalafilDocumentation & Change Control
2026-04-15Class IPure Vitamins and Natural Supplements, LLCH-0655-2026FDA analysis revealed the presence of undeclared sildenafilDocumentation & Change Control
2026-04-15Class IPure Vitamins and Natural Supplements, LLCH-0654-2026FDA analysis revealed the presence of undeclared sildenafilDocumentation & Change Control
2026-04-15Class IITeva Pharmaceuticals USA, IncD-0474-2026CGMP Deviations: use of an unapproved raw materialDocumentation & Change Control
2026-04-15Class IITornier, IncZ-1769-2026Affected products were incorrectly labeled as Tornier HRS Max products. These parts are compatible with the Tornier HRS system only, and are incompatible with the Tornier HRS Max system.Documentation & Change Control
2026-04-15Class IITeva Pharmaceuticals USA, IncD-0472-2026CGMP Deviations: use of an unapproved raw materialDocumentation & Change Control
2026-04-08Class IICivco Medical Instruments Co. Inc.Z-1731-2026There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.Documentation & Change Control
2026-04-08Class IICivco Medical Instruments Co. Inc.Z-1737-2026There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.Documentation & Change Control
2026-04-08Class IICivco Medical Instruments Co. Inc.Z-1735-2026There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.Documentation & Change Control
2026-04-08Class IICivco Medical Instruments Co. Inc.Z-1732-2026There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.Documentation & Change Control
2026-04-08Class IAmneal Pharmaceuticals, LLCD-0478-2026Product mix up: a foil pouch labeled "Magnesium Sulfate in Water for Injection, 4 g/100 mL" actually contained an IV bag of Tranexamic Acid instead.Documentation & Change Control
2026-04-08Class IIHEYTEA USA INCH-0646-2026Product contains undeclared milk.Documentation & Change Control
2026-04-08Class IIThe Maros Group, LLCH-0644-2026Undeclared sulfites.Documentation & Change Control
2026-04-08Class IIIPocas International Corp.H-0633-2026Packaging integrity issue that may compromise product quality .Documentation & Change Control
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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.