Sterility failure recalls

6589 matching FDA recall record(s) · checked Oct 24, 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 II2026-10-14LEADER DRY EYE RELIEF EYE DROPSLack of Assurance of SterilityRecalling firm: K.C. Pharmaceuticals, Inc.Read what it means & check your lot →Class II2026-10-14QUAD-MIX( PAPAV/PHENTO/ALPROS/TROP) INJECTABLE, Packaged in single-useLack of Assurance of Sterility: Related to processing equipment used in compounded product.Recalling firm: Carolina Infusion, LLCRead what it means & check your lot →Class II2026-10-14TIRZEPATIDE/CYANOCOBALAMIN 26/2 MG/ML INJECTABLE, Packaged in single-uLack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.Recalling firm: Carolina Infusion, LLCRead what it means & check your lot →Class II2026-10-14Tri-MIX (PAPAV/PHENTO/ALPROS),30/1/20, injectable, Packaged in singleLack of Assurance of Sterility: Related to processing equipment used in compounded product.Recalling firm: Carolina Infusion, LLCRead what it means & check your lot →Class II2026-10-14Tri-MIX (PAPAV/PHENTO/ALPROS),30/1/10, injectable, Packaged in singleLack of Assurance of Sterility: Related to processing equipment used in compounded product.Recalling firm: Carolina Infusion, LLCRead what it means & check your lot →Class II2026-10-14Tri-MIX (PAPAV/PHENTO/ALPROS),30/1/60, injectable, Packaged in single-Lack of Assurance of Sterility: Related to processing equipment used in compounded product.Recalling firm: Carolina Infusion, LLCRead what it means & check your lot →Class II2026-10-14LEADER ADVANCED RELIEF EYE DROPSLack of Assurance of SterilityRecalling firm: K.C. Pharmaceuticals, Inc.Read what it means & check your lot →Class II2026-10-14Tri-MIX (PAPAV/PHENTO/ALPROS),30/2/40, Packaged in single-use dosage sLack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.Recalling firm: Carolina Infusion, LLCRead what it means & check your lot →Class II2026-10-14GOODSENSE EYE DROPS ORIGINAL FORMULALack of Assurance of SterilityRecalling firm: K.C. Pharmaceuticals, Inc.Read what it means & check your lot →Class II2026-10-14Tri-MIX (PAPAV/PHENTO/ALPROS), 30/1/40, injectable, Packaged in singleLack of Assurance of Sterility: Related to processing equipment used in compounded product.Recalling firm: Carolina Infusion, LLCRead what it means & check your lot →Class II2026-10-14Tirzepatide Injection, 18mg/mL, 4 mL Sterile Multi-Dose Vial, Rx only,Lack of Assurance of SterilityRecalling firm: Apothecary Pharma LLCRead what it means & check your lot →Class II2026-10-14Tri-MIX (PAPAV/PHENTO/ALPROS),30/2/20, injectable, Packaged in single-Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.Recalling firm: Carolina Infusion, LLCRead what it means & check your lot →Class II2026-10-14TIRZEPATIDE/CYANOCOBALAMIN 85/2 MG/ML INJECTABLE, Packaged in single-uLack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.Recalling firm: Carolina Infusion, LLCRead what it means & check your lot →Class II2026-10-14LEADER ULTRA LUBRICATING EYE DROPSLack of Assurance of SterilityRecalling firm: K.C. Pharmaceuticals, Inc.Read what it means & check your lot →Class II2026-10-14TIRZEPATIDE/CYANOCOBALAMIN 64/2 MG/ML INJECTABLE, Packaged in single-uLack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.Recalling firm: Carolina Infusion, LLCRead what it means & check your lot →Class II2026-10-14TARGET EYE DROPS MAXIMUM REDNESS RELIEF EYELack of Assurance of SterilityRecalling firm: K.C. Pharmaceuticals, Inc.Read what it means & check your lot →Class II2026-10-14TIRZEPATIDE/CYANOCOBALAMIN 76/2 MG/ML INJECTABLE, Packaged in single-uLack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.Recalling firm: Carolina Infusion, LLCRead what it means & check your lot →Class II2026-10-14TIRZEPATIDE 26 MG/ML INJECTABLE, Packaged in single-use dosage syringeLack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.Recalling firm: Carolina Infusion, LLCRead what it means & check your lot →Class II2026-10-14LEADER ARTIFICIAL TEARS 15 MLLack of Assurance of SterilityRecalling firm: K.C. Pharmaceuticals, Inc.Read what it means & check your lot →Class II2026-10-14SEMAGLUTIDE/CYANOCOBALAMIN 9/2 MG/ML INJECTABLE, Packaged in single-usLack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.Recalling firm: Carolina Infusion, LLCRead what it means & check your lot →Class II2026-10-14GOODSENSE EYE DROPS IRRITATION RELIEFLack of Assurance of SterilityRecalling firm: K.C. Pharmaceuticals, Inc.Read what it means & check your lot →Class II2026-10-14SEMAGLUTIDE/CYANOCOBALAMIN 3/2 MG/ML INJECTABLE, Packaged in single-uLack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.Recalling firm: Carolina Infusion, LLCRead what it means & check your lot →Class II2026-10-14SEMAGLUTIDE 3 MG/ML INJECTABLE, 8 x 0.1 mL syringes, Carolina InfusionLack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.Recalling firm: Carolina Infusion, LLCRead what it means & check your lot →Class II2026-10-14SERMORELIN ACETATE 1 MG/ML INJECTABLE, Packaged in single-use dosage sLack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.Recalling firm: Carolina Infusion, LLCRead what it means & check your lot →Class II2026-10-14LEADER EYE DROPS REDNESS RELIEFLack of Assurance of SterilityRecalling firm: K.C. Pharmaceuticals, Inc.Read what it means & check your lot →Class II2026-10-14Apothecary NAD+ Injection 200 mg/mL, 6 mL Sterile Multi-Dose Vial, Rx Lack of Assurance of SterilityRecalling firm: Apothecary Pharma LLCRead what it means & check your lot →Class II2026-10-07FOCUS PILack of Assurance of SterilityRecalling firm: Aurolab TrustRead what it means & check your lot →Class II2026-09-30GENTLE EYES LUBRICANT EYE DROPSLack of Assurance of SterilityRecalling firm: Sterling Pharmaceutical Services LLCRead what it means & check your lot →Class II2026-09-30CARBOXYMETHYLCELLULOSE SODIUMLack of Assurance of SterilityRecalling firm: Sterling Pharmaceutical Services LLCRead what it means & check your lot →Class II2026-09-30Clear Eyes Redness Relief, Lubricant/Redness Reliever Eye Drops (glyceLack of Assurance of SterilityRecalling firm: Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare companyRead what it means & check your lot →Class II2026-09-30CARBOXYMETHYLCELLULOSE SODIUMLack of Assurance of SterilityRecalling firm: Sterling Pharmaceutical Services LLCRead what it means & check your lot →Class II2026-09-30Lubricant Eye Drops-Cameron Pharmaceuticals, Carboxymethylcellulose SoLack of Assurance of SterilityRecalling firm: Sterling Pharmaceutical Services LLCRead what it means & check your lot →Class II2026-09-30SODIUM CHLORIDE HYPERTONICITY OPHTHALMIC SOLUTION, 5%Lack of Assurance of SterilityRecalling firm: Sterling Pharmaceutical Services LLCRead what it means & check your lot →Class II2026-09-30WALGREENS LUBRICANT EYE DROPSLack of Assurance of SterilityRecalling firm: Sterling Pharmaceutical Services LLCRead what it means & check your lot →Class II2026-09-30Major LubriFresh P.M. Nighttime Ointment, Net wt. 0.125 oz. (3.5 g) tuLack of Assurance of SterilityRecalling firm: Sterling Pharmaceutical Services LLCRead what it means & check your lot →Class II2026-09-30WALGREENS LUBRICANT EYE DROPSLack of Assurance of SterilityRecalling firm: Sterling Pharmaceutical Services LLCRead what it means & check your lot →Class II2026-09-30Clear Eyes Redness Relief, Lubricant/Redness Reliever Eye Drops (glyceLack of Assurance of SterilityRecalling firm: Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare companyRead what it means & check your lot →Class II2026-09-30LUBRICATING TEARSLack of Assurance of SterilityRecalling firm: Sterling Pharmaceutical Services LLCRead what it means & check your lot →Class II2026-09-23DOPAMINE HYDROCHLORIDELack of Assurance of SterilityRecalling firm: PfizerRead what it means & check your lot →Class I2026-09-16EPINEPHRINEPresence of Particulate Matter and Lack of Assurance of Sterility. Particulate matter identified as nylon, cellulosic, acrylic, polyethylene and glass and broken and leaking vials.Recalling firm: American Regent, Inc.Read what it means & check your lot →Class II2026-08-26LIBTAYOLack of Assurance of SterilityRecalling firm: Regeneron Pharmaceuticals IncRead what it means & check your lot →Class II2026-08-19CLEAR EYES Maximum Itchy Eye Relief, 0.5 fl oz (15 mL) per dropper botLack of assurance of sterility. The recall is due to potential contaminationRecalling firm: Prestige Brands HoldingsRead 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 II2026-07-29ROHTOLack 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 →

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