Sterility failure recalls

6547 matching FDA recall record(s) · checked Aug 25, 2026

What this means

Products meant to be sterile — injectables, eye drops, some inhalation products — are recalled when the manufacturer cannot assure sterility. A non-sterile injectable or ophthalmic product carries a real infection risk.

Recalls with this cause

Class II2026-07-29ROHTOLack of Assurance of SterilityRecalling firm: Rohto-Mentholatum (Vietnam) Co., Ltd.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 II2026-07-29ROHTO DIGI-EYELack of Assurance of SterilityRecalling firm: Rohto-Mentholatum (Vietnam) Co., Ltd.Read 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 II2026-07-29ROHTOLack of Assurance of SterilityRecalling firm: Rohto-Mentholatum (Vietnam) Co., Ltd.Read 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 II2026-07-29ROHTOLack of Assurance of SterilityRecalling firm: Rohto-Mentholatum (Vietnam) Co., Ltd.Read 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 II2026-07-22CHLORAPREP 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 II2026-07-15Pemetrexed for Injection 500mg/Vial, 1 50 mL Single-Dose Vial per cartLack of Sterility AssuranceRecalling firm: Reliance Life Sciences Private LimitedRead what it means & check your lot →Class II2026-07-15Bortezomib for Injection 3.5mg/Vial, 10 mL per Single-Dose Vial, For ILack of Sterility AssuranceRecalling firm: Reliance Life Sciences Private LimitedRead what it means & check your lot →Class II2026-07-15Pemetrexed for Injection 100mg/Vial, 1 10 mL Single-Dose Vial per cartLack of Sterility AssuranceRecalling firm: Reliance Life Sciences Private LimitedRead what it means & check your lot →Class II2026-07-15Azacitidine for Injection 100mg/Vial, 1 10 mL Single-Dose Vial per carLack of Sterility AssuranceRecalling firm: Reliance Life Sciences Private LimitedRead what it means & check your lot →Class II2026-07-08CHLORAPREP ONE-STEPLack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of thRecalling firm: CareFusion 213, LLCRead what it means & check your lot →Class II2026-07-08CHLORAPREP ONE-STEPLack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of thRecalling firm: CareFusion 213, LLCRead what it means & check your lot →Class II2026-07-08ACCUCAINELack of Assurance of SterilityRecalling firm: Asclemed USA Inc.Read what it means & check your lot →Class II2026-07-08CHLORAPREP ONE-STEPLack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of thRecalling firm: CareFusion 213, LLCRead what it means & check your lot →Class I2026-07-08Revitaderm Wound Care Gel, Benzalkonium Chloride 0.1%, packaged in 1.0Microbial contamination of Non-Sterile Product: samples identified the presence of Lysinibacillus fusiformis and other Bacillus sppRecalling firm: Blaine Labs IncRead what it means & check your lot →Class II2026-07-08CHLORAPREP ONE-STEPLack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of thRecalling firm: CareFusion 213, LLCRead what it means & check your lot →Class II2026-07-08CHLORAPREP ONE-STEPLack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of thRecalling firm: CareFusion 213, LLCRead what it means & check your lot →Class II2026-07-08PURPREPLack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of thRecalling firm: CareFusion 213, LLCRead what it means & check your lot →Class II2026-07-08LIDOCAINE HYDROCHLORIDELack of Assurance of SterilityRecalling firm: Asclemed USA Inc.Read what it means & check your lot →Class II2026-07-08IMULDOSALack of assurance of Sterility:Recalling firm: ACCORD BIOPHARMA INCRead what it means & check your lot →Class II2026-07-08CHLORAPREP ONE-STEPLack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of thRecalling firm: CareFusion 213, LLCRead what it means & check your lot →Class II2026-07-08CHLORAPREP ONE-STEPLack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of thRecalling firm: CareFusion 213, LLCRead what it means & check your lot →Class II2026-07-08CHLORAPREP ONE-STEPLack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of thRecalling firm: CareFusion 213, LLCRead what it means & check your lot →Class II2026-07-08CHLORAPREP ONE-STEPLack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of thRecalling firm: CareFusion 213, LLCRead what it means & check your lot →Class II2026-07-01CHLORAPREP ONE-STEPLack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.Recalling firm: CareFusion 213, LLCRead what it means & check your lot →Class II2026-07-01CHLORAPREP ONE-STEPLack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.Recalling firm: CareFusion 213, LLCRead what it means & check your lot →Class II2026-07-01PReye Vitamin See Antioxidant Preservative Free Eye Drops, DistributedLack of Assurance of SterilityRecalling firm: PReye LLCRead what it means & check your lot →Class I2026-07-01CHLORAPREP ONE-STEPNon-Sterility: Due to presence of Aspergillus penicillioides.Recalling firm: CareFusion 213, LLCRead what it means & check your lot →Class I2026-07-01CHLORAPREP ONE-STEPNon-Sterility: Due to presence of Aspergillus penicillioides. And Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.Recalling firm: CareFusion 213, LLCRead what it means & check your lot →Class I2026-06-17BEEKEEPER'S NATURALS Saline Nasal Spray, Sinus Congestion Rinse, Made Microbial Contamination of Non-Sterile ProductsRecalling firm: BEEKEEPER'S NATURALS USA INC.Read what it means & check your lot →Class II2026-06-10LIDOCAINE HYDROCHLORIDELack of Assurance of SterilityRecalling firm: Spectra Medical Devices, LlcRead what it means & check your lot →Class I2026-05-27MG217 Multi-Symptom Treatment Cream & Skin Protectant (colloidal oatmeMicrobial Contamination of Non-Sterile Products: confirmed presence of Staphylococcus Aureus.Recalling firm: Wisconsin Pharmacal CompanyRead what it means & check your lot →Class II2026-05-27CIMZIALack of Assurance of SterilityRecalling firm: UCB Biosciences Inc.Read what it means & check your lot →Class II2026-05-20OASIS TEARS PFLack of Assurance of Sterility: The recall is being initiated out of an abundance of caution following FDA observations noted during a recent inspection of Excelvision.Recalling firm: Oasis Medical, Inc.Read what it means & check your lot →Class II2026-05-13PURPREPLack of assurance of Sterility: potential product contaminationRecalling firm: CareFusion 213, LLCRead what it means & check your lot →Class II2026-05-13PURPREPLack of assurance of Sterility: potential product contaminationRecalling firm: CareFusion 213, LLCRead what it means & check your lot →Class II2026-05-13DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safeLack of Assurance of Sterility: Potential leaks from perforations in bags.Recalling firm: Fresenius Medical Care Holdings, Inc.Read what it means & check your lot →Class II2026-05-13OCTREOTIDE ACETATELack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.Recalling firm: Teva Pharmaceuticals USA, IncRead what it means & check your lot →Class II2026-05-13DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safeLack of Assurance of Sterility: Potential leaks from perforations in bags.Recalling firm: Fresenius Medical Care Holdings, Inc.Read what it means & check your lot →Class II2026-05-06Similasan, iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 FLack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.Recalling firm: Thea Pharma, Inc.Read what it means & check your lot →Class II2026-05-06IVIZIA DRY EYELack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.Recalling firm: Thea Pharma, Inc.Read what it means & check your lot →Class II2026-05-06GENTEAL TEARSLack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.Recalling firm: Alcon Research LLCRead what it means & check your lot →Class II2026-05-06OPTASELack of Assurance of SterilityRecalling firm: SCOPE HEALTHRead what it means & check your lot →Class II2026-05-06SYSTANELack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.Recalling firm: Alcon Research LLCRead what it means & check your lot →Class II2026-04-29FRESHKOTE LUBRICANT EYEDROPS, Sterile, 0.33 FL OZ (10mL), Harrow Eye LLack of Assurance of SterilityRecalling firm: Harrow Eye LLCRead what it means & check your lot →Class II2026-04-29DEXTROSELack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.Recalling firm: B BRAUN MEDICAL INCRead what it means & check your lot →Class II2026-04-29LACTATED RINGERS IRRIGATIONLack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.Recalling firm: B BRAUN MEDICAL INCRead what it means & check your lot →Class II2026-04-29SODIUM CHLORIDE FOR IRRIGATIONLack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.Recalling firm: B BRAUN MEDICAL INCRead what it means & check your lot →Class II2026-04-29STERILE WATERLack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.Recalling firm: B BRAUN MEDICAL INCRead what it means & check your lot →Class II2026-04-22Semaglutide-Glycine-Cyanocobalamin Injectable, 2.5 mg, 5 mg, 1 MG/ML, Lack of Assurance of SterilityRecalling firm: PAYLESS COMPOUNDERS, LLCRead what it means & check your lot →Class II2026-04-22EPINEPHRINELack of Assurance of SterilityRecalling firm: International Medication Systems Ltd.Read what it means & check your lot →Class II2026-04-22SODIUM CHLORIDELack of Assurance of SterilityRecalling firm: Huons Co., Ltd.Read what it means & check your lot →Class II2026-04-22BUPIVACAINE HYDROCHLORIDELack of Assurance of SterilityRecalling firm: Huons Co., Ltd.Read what it means & check your lot →Class II2026-04-22LIDOCAINE HYDROCHLORIDELack of Assurance of SterilityRecalling firm: Huons Co., Ltd.Read what it means & check your lot →Class II2026-04-22LIDOCAINE HYDROCHLORIDELack of Assurance of SterilityRecalling firm: Huons Co., Ltd.Read what it means & check your lot →Class II2026-04-15Vancomycin HCI, 1.5 grams added to 250 mL, 0.9% Sodium Chloride InjectLack of Assurance of Sterility; blue Break-Off-Part could detach from the administration portRecalling firm: Fagron Compounding ServicesRead what it means & check your lot →

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