Class II drug recalls: what it means, and the current list

727 Class II drug recall(s) in the last 12 months · checked Aug 25, 2026

What is a Class II recall?

FDA classifies a Class II recall as one where the product is temporary or reversible harm; serious harm is unlikely (FDA's definition). Class I is the most serious, Class III the least. The class reflects FDA's risk assessment of the defect, not whether your specific lot is involved — always match your lot number to the record.

Current Class II drug recalls

Class II2026-08-12DICYCLOMINE HYDROCHLORIDEshortfill; reports of empty capsules.Recalling firm: Aurobindo Pharma USA IncRead what it means & check your lot →Class II2026-08-12MIRABEGRONCGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.Recalling firm: Zydus Pharmaceuticals (USA) IncRead what it means & check your lot →Class II2026-08-05AZELAIC ACIDCGMP Deviations: Product quality complaints concerning abnormal texture or consistency (described as grainy, gritty, or sandy) were received.Recalling firm: Glenmark Pharmaceuticals Inc., USARead what it means & check your lot →Class II2026-08-05MYCOPHENOLATE MOFETILPresence of precipitateRecalling firm: MYLAN PHARMACEUTICALS INCRead what it means & check your lot →Class II2026-08-05DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE OPHTHALMIC SOLUTIONDefective Container: Firm received multiple complaints of broken cap spikes and undeliverable drops.Recalling firm: MICRO LABS USA INCRead what it means & check your lot →Class II2026-07-29ROHTOLack of Assurance of SterilityRecalling firm: Rohto-Mentholatum (Vietnam) Co., Ltd.Read what it means & check your lot →Class II2026-07-29LEVOTHYROXINE SODIUMSubpotent DrugRecalling firm: Major PharmaceuticalsRead what it means & check your lot →Class II2026-07-29ROHTOLack of Assurance of SterilityRecalling firm: Rohto-Mentholatum (Vietnam) Co., Ltd.Read what it means & check your lot →Class II2026-07-29LEVOTHYROXINE SODIUMSubpotent DrugRecalling firm: Major PharmaceuticalsRead what it means & check your lot →Class II2026-07-29LEVOTHYROXINE SODIUMSubpotent DrugRecalling firm: Major PharmaceuticalsRead what it means & check your lot →Class II2026-07-29NAROPINPresence of Particulate Matter: Hair was found in productsRecalling firm: Fresenius Kabi USA, LLCRead what it means & check your lot →Class II2026-07-29LEVOTHYROXINE SODIUMSubpotent DrugRecalling firm: Major PharmaceuticalsRead what it means & check your lot →Class II2026-07-29LEVOTHYROXINE SODIUMSubpotent DrugRecalling firm: Major PharmaceuticalsRead what it means & check your lot →Class II2026-07-29LEVOTHYROXINE SODIUMSubpotent DrugRecalling firm: Major PharmaceuticalsRead what it means & check your lot →Class II2026-07-29ROHTO DIGI-EYELack of Assurance of SterilityRecalling firm: Rohto-Mentholatum (Vietnam) Co., Ltd.Read what it means & check your lot →Class II2026-07-29XYLOCAINEPresence of Particulate Matter: Hair was found in productsRecalling firm: Fresenius Kabi USA, LLCRead what it means & check your lot →Class II2026-07-29ROHTO DRY-AIDLack of Assurance of SterilityRecalling firm: Rohto-Mentholatum (Vietnam) Co., Ltd.Read what it means & check your lot →Class II2026-07-29LEVOTHYROXINE SODIUMSubpotent DrugRecalling firm: Major PharmaceuticalsRead what it means & check your lot →Class II2026-07-29LIDOCAINEPresence of Particulate Matter: Hair was found in productsRecalling firm: Fresenius Kabi USA, LLCRead what it means & check your lot →Class II2026-07-29ROHTOLack of Assurance of SterilityRecalling firm: Rohto-Mentholatum (Vietnam) Co., Ltd.Read what it means & check your lot →Class II2026-07-29DIVALPROEX SODIUMPresence of Foreign Tablets/CapsulesRecalling firm: Bionpharma Inc.Read what it means & check your lot →Class II2026-07-29AMLODIPINE AND OLMESARTAN MEDOXOMILFailed Dissolution Specifications; Olmesartan Medoxomil content below specificationsRecalling firm: Ascend Laboratories, LLCRead what it means & check your lot →Class II2026-07-29LEVOTHYROXINE SODIUMSubpotent DrugRecalling firm: Major PharmaceuticalsRead what it means & check your lot →Class II2026-07-29LEVOTHYROXINE SODIUMSubpotent DrugRecalling firm: Major PharmaceuticalsRead what it means & check your lot →Class II2026-07-29ROHTO OPTIC GLOWLack of Assurance of SterilityRecalling firm: Rohto-Mentholatum (Vietnam) Co., Ltd.Read what it means & check your lot →Class II2026-07-29XYLOCAINEPresence of Particulate Matter: Hair was found in productsRecalling firm: Fresenius Kabi USA, LLCRead what it means & check your lot →Class II2026-07-29GLYCOPYRROLATEPresence of Particulate Matter: Hair was found in productRecalling firm: Fresenius Kabi USA, LLCRead what it means & check your lot →Class II2026-07-29LEVOTHYROXINE SODIUMSubpotent DrugRecalling firm: Major PharmaceuticalsRead what it means & check your lot →Class II2026-07-29GLYCOPYRROLATEFailed Impurities/Degradation SpecificationsRecalling firm: Precision Dose Inc.Read what it means & check your lot →Class II2026-07-29LEVOTHYROXINE SODIUMSubpotent DrugRecalling firm: Major PharmaceuticalsRead what it means & check your lot →Class II2026-07-29CYPROHEPTADINE HYDROCHLORIDEPresence of Precipitate: medication was crystallizing and particles floating in the bottleRecalling firm: Rising Pharma Holding, Inc.Read what it means & check your lot →Class II2026-07-29ROHTOLack of Assurance of SterilityRecalling firm: Rohto-Mentholatum (Vietnam) Co., Ltd.Read what it means & check your lot →Class II2026-07-29LEVOTHYROXINE SODIUMSubpotent DrugRecalling firm: Major PharmaceuticalsRead what it means & check your lot →Class II2026-07-29ROHTO DRY-AIDLack of Assurance of SterilityRecalling firm: Rohto-Mentholatum (Vietnam) Co., Ltd.Read what it means & check your lot →Class II2026-07-22CLEVIPREXLack of Assurance of SterilityRecalling firm: Chiesi USA, Inc.Read what it means & check your lot →Class II2026-07-22QUALITY CHOICE EARWAX REMOVAL KITSubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).Recalling firm: Bell Pharmaceuticals, IncRead what it means & check your lot →Class II2026-07-22CLINERE EAR WAX REMOVERSubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).Recalling firm: Bell Pharmaceuticals, IncRead what it means & check your lot →Class II2026-07-22LEADER EARWAX REMOVAL KIT EARWAX REMOVAL AID AND BULBSubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).Recalling firm: Bell Pharmaceuticals, IncRead what it means & check your lot →Class II2026-07-22FAMILY WELLNESS EARWAX REMOVAL EARWAX AND BULBSubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).Recalling firm: Bell Pharmaceuticals, IncRead what it means & check your lot →Class II2026-07-22CHLORAPREP ONE-STEPLack of Assurance of Sterility: Affected product may exhibit an open or incomplete seal on the packaging of the applicatorRecalling firm: CareFusion 213, LLCRead what it means & check your lot →Class II2026-07-22CAREONE EARWAX REMOVAL DROPSSubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).Recalling firm: Bell Pharmaceuticals, IncRead what it means & check your lot →Class II2026-07-22NYSTATINSubpotent Drug: Low out of specification assay results performed during long-term stability testing.Recalling firm: Padagis US LLCRead what it means & check your lot →Class II2026-07-22MEIJER EARWAX REMOVAL KITSubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).Recalling firm: Bell Pharmaceuticals, IncRead what it means & check your lot →Class II2026-07-22CVS HEALTH EARWAX REMOVAL DROPS EARWAX REMOVAL AIDSubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).Recalling firm: Bell Pharmaceuticals, IncRead what it means & check your lot →Class II2026-07-22TOPCARE EARWAX REMOVAL KITSubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).Recalling firm: Bell Pharmaceuticals, IncRead what it means & check your lot →Class II2026-07-22AUDIOLOGISTS CHOICE EARWAX REMOVAL SYSTEMSubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).Recalling firm: Bell Pharmaceuticals, IncRead what it means & check your lot →Class II2026-07-22GOOD NEIGHBOR PHARMACY EARWAX REMOVALSubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).Recalling firm: Bell Pharmaceuticals, IncRead what it means & check your lot →Class II2026-07-22Foster & Thrive, Carbamide Peroxide 6.5%, 0.5 FL OZ (15 mL), NDC 70677SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).Recalling firm: Bell Pharmaceuticals, IncRead what it means & check your lot →Class II2026-07-15METHOHEXITAL SODIUMFailed Impurities/Degradation SpecificationsRecalling firm: ONESOURCE SPECIALTY PHARMA LIMITEDRead what it means & check your lot →Class II2026-07-15Gasco Isopropyl Alcohol 70%, Net Contents: 1 US Gallon (3.78 L), ManufSubpotent drugRecalling firm: Gasco Industrial Corp.Read what it means & check your lot →