Sterility failure recalls

6514 matching FDA recall record(s) · checked Jul 05, 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 IBEEKEEPER'S NATURALS Saline Nasal Spray, Sinus Congestion Rinse, Made 2026-06-17
Microbial Contamination of Non-Sterile Products
Recalling firm: BEEKEEPER'S NATURALS USA INC.
Class IILIDOCAINE HYDROCHLORIDE2026-06-10
Lack of Assurance of Sterility
Recalling firm: Spectra Medical Devices, Llc
Class IMG217 Multi-Symptom Treatment Cream & Skin Protectant (colloidal oatme2026-05-27
Microbial Contamination of Non-Sterile Products: confirmed presence of Staphylococcus Aureus.
Recalling firm: Wisconsin Pharmacal Company
Class IICIMZIA2026-05-27
Lack of Assurance of Sterility
Recalling firm: UCB Biosciences Inc.
Class IIOASIS TEARS PF2026-05-20
Lack 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.
Class IIPURPREP2026-05-13
Lack of assurance of Sterility: potential product contamination
Recalling firm: CareFusion 213, LLC
Class IIPURPREP2026-05-13
Lack of assurance of Sterility: potential product contamination
Recalling firm: CareFusion 213, LLC
Class IIDELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe2026-05-13
Lack of Assurance of Sterility: Potential leaks from perforations in bags.
Recalling firm: Fresenius Medical Care Holdings, Inc.
Class IIOCTREOTIDE ACETATE2026-05-13
Lack 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, Inc
Class IIDELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe2026-05-13
Lack of Assurance of Sterility: Potential leaks from perforations in bags.
Recalling firm: Fresenius Medical Care Holdings, Inc.
Class IISimilasan, iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 F2026-05-06
Lack 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.
Class IIIVIZIA DRY EYE2026-05-06
Lack 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.
Class IIGENTEAL TEARS2026-05-06
Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.
Recalling firm: Alcon Research LLC
Class IIOPTASE2026-05-06
Lack of Assurance of Sterility
Recalling firm: SCOPE HEALTH
Class IISYSTANE2026-05-06
Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.
Recalling firm: Alcon Research LLC
Class IIFRESHKOTE LUBRICANT EYEDROPS, Sterile, 0.33 FL OZ (10mL), Harrow Eye L2026-04-29
Lack of Assurance of Sterility
Recalling firm: Harrow Eye LLC
Class IIDEXTROSE2026-04-29
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
Recalling firm: B BRAUN MEDICAL INC
Class IILACTATED RINGERS IRRIGATION2026-04-29
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
Recalling firm: B BRAUN MEDICAL INC
Class IISODIUM CHLORIDE FOR IRRIGATION2026-04-29
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
Recalling firm: B BRAUN MEDICAL INC
Class IISTERILE WATER2026-04-29
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
Recalling firm: B BRAUN MEDICAL INC
Class IISemaglutide-Glycine-Cyanocobalamin Injectable, 2.5 mg, 5 mg, 1 MG/ML, 2026-04-22
Lack of Assurance of Sterility
Recalling firm: PAYLESS COMPOUNDERS, LLC
Class IIEPINEPHRINE2026-04-22
Lack of Assurance of Sterility
Recalling firm: International Medication Systems Ltd.
Class IISODIUM CHLORIDE2026-04-22
Lack of Assurance of Sterility
Recalling firm: Huons Co., Ltd.
Class IIBUPIVACAINE HYDROCHLORIDE2026-04-22
Lack of Assurance of Sterility
Recalling firm: Huons Co., Ltd.
Class IILIDOCAINE HYDROCHLORIDE2026-04-22
Lack of Assurance of Sterility
Recalling firm: Huons Co., Ltd.
Class IILIDOCAINE HYDROCHLORIDE2026-04-22
Lack of Assurance of Sterility
Recalling firm: Huons Co., Ltd.
Class IIVancomycin HCI, 1.5 grams added to 250 mL, 0.9% Sodium Chloride Inject2026-04-15
Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
Recalling firm: Fagron Compounding Services
Class IISODIUM CHLORIDE2026-04-15
Lack of Assurance of Sterility
Recalling firm: Fresenius Kabi USA, LLC
Class IISODIUM CHLORIDE2026-04-15
Lack of Assurance of Sterility
Recalling firm: Fresenius Kabi USA, LLC
Class IISODIUM CHLORIDE2026-04-15
Lack of Assurance of Sterility
Recalling firm: Fresenius Kabi USA, LLC
Class IISODIUM CHLORIDE2026-04-15
Lack of Assurance of Sterility
Recalling firm: Fresenius Kabi USA, LLC
Class IISODIUM CHLORIDE2026-04-15
Lack of Assurance of Sterility
Recalling firm: Fresenius Kabi USA, LLC
Class IIVancomycin HCI, 1.25 grams added to 250 mL, 0.9% Sodium Chloride Injec2026-04-15
Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
Recalling firm: Fagron Compounding Services
Class IISODIUM CHLORIDE2026-04-15
Lack of Assurance of Sterility
Recalling firm: Fresenius Kabi USA, LLC
Class IILANREOTIDE ACETATE2026-04-15
Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection procedure.
Recalling firm: Cipla USA, Inc.
Class IIDEXTROSE2026-04-15
Lack of Assurance of Sterility
Recalling firm: Fresenius Kabi USA, LLC
Class IInorepinephrine Bitartrate, 32mg per 250mL 0.9% Sodium Chloride Injecti2026-04-15
Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
Recalling firm: Fagron Compounding Services
Class IIDEXTROSE2026-04-15
Lack of Assurance of Sterility
Recalling firm: Fresenius Kabi USA, LLC
Class IIDEXTROSE2026-04-15
Lack of Assurance of Sterility
Recalling firm: Fresenius Kabi USA, LLC
Class IISODIUM CHLORIDE2026-04-15
Lack of Assurance of Sterility
Recalling firm: Fresenius Kabi USA, LLC
Class IIARTIFICIAL TEARS2026-04-15
Lack of Assurance of Sterility
Recalling firm: Preferred Pharmaceuticals, Inc.
Class IInorepinephrine Bitartrate,16mg per 250mL 0.9% Sodium Chloride Injectio2026-04-15
Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
Recalling firm: Fagron Compounding Services
Class IISODIUM CHLORIDE2026-04-15
Lack of Assurance of Sterility
Recalling firm: Fresenius Kabi USA, LLC
Class IISODIUM CHLORIDE2026-04-15
Lack of Assurance of Sterility
Recalling firm: Fresenius Kabi USA, LLC
Class IISODIUM CHLORIDE2026-04-15
Lack of Assurance of Sterility
Recalling firm: Fresenius Kabi USA, LLC
Class IIVancomycin HCL, 1 gram added to 250 mL, 0.9% Sodium Chloride Injection2026-04-15
Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
Recalling firm: Fagron Compounding Services
Class IISODIUM CHLORIDE2026-04-15
Lack of Assurance of Sterility
Recalling firm: Fresenius Kabi USA, LLC
Class IILANREOTIDE ACETATE2026-04-15
Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection procedure.
Recalling firm: Cipla USA, Inc.
Class IILEADER ARTIFICIAL TEARS 15 ML2026-04-08
Lack of Assurance of Sterility
Recalling firm: K.C. Pharmaceuticals, Inc
Class IILEADER ULTRA LUBRICATING EYE DROPS2026-04-08
Lack of Assurance of Sterility
Recalling firm: K.C. Pharmaceuticals, Inc
Class IIGOODSENSE EYE DROPS ORIGINAL FORMULA2026-04-08
Lack of Assurance of Sterility
Recalling firm: K.C. Pharmaceuticals, Inc
Class IIARTIFICIAL TEARS2026-04-08
Lack of Assurance of Sterility
Recalling firm: K.C. Pharmaceuticals, Inc
Class IIGNP EYE DROPS REDNESS AND DRY EYE RELIEF2026-04-08
Lack of Assurance of Sterility
Recalling firm: K.C. Pharmaceuticals, Inc
Class IIQUALITY CHOICE MOISTURIZING RELIEF EYE DROPS2026-04-08
Lack of Assurance of Sterility
Recalling firm: K.C. Pharmaceuticals, Inc
Class IIQUALITY CHOICE EYE DROPS IRRITATION RELIEF2026-04-08
Lack of Assurance of Sterility
Recalling firm: K.C. Pharmaceuticals, Inc
Class IISTERILE EYE DROPS SOOTHING TEARS (polyethylene glycol 400 0.4% and pro2026-04-08
Lack of Assurance of Sterility
Recalling firm: K.C. Pharmaceuticals, Inc
Class IIOCTREOTIDE ACETATE2026-04-01
Lack 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, Inc
Class IIOCTREOTIDE ACETATE2026-04-01
Lack 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, Inc
Class IIOCTREOTIDE ACETATE2026-04-01
Lack 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, Inc
Class IICUROSURF2026-04-01
Lack of Assurance of Sterility
Recalling firm: Chiesi USA, Inc.

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