Microbial contamination recalls

1231 matching FDA recall record(s) · checked Aug 25, 2026

What this means

Microbial contamination — bacteria (such as Burkholderia cepacia) or fungi found in a product — is a frequent recall cause, especially for liquids, nasal sprays, and non-sterile products where organisms can grow. It can be serious for immunocompromised patients.

Recalls with this cause

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 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 II2026-06-17Zep, Alcohol Sanitizer Spray, Ethanol 70%, Net Contents 55 Gallons 208Microbial contamination of sterile productsRecalling firm: Zep IncRead 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 I2026-03-25Webcol Alcohol Prep pad (70% isopropyl alcohol) 2 ply, 200 count boxesNon-Sterility: microbial contamination identified as Paenibacillus phoenicisRecalling firm: Cardinal Health 200, LLCRead what it means & check your lot →Class II2026-03-11Semaglutide, For Rx compounding use only, packaged in a) 1g, NDC 8438CGMP Deviations This recall has been initiated due to failing to complete process validation and bacterial endotoxin method validation before distributionRecalling firm: Harbin Jixianglong Biotech Co., Ltd.Read what it means & check your lot →Class II2026-03-11Semaglutide, For Rx compounding use only, packaged in a) 1g, NDC 84385CGMP Deviations This recall has been initiated due to failing to complete process validation and bacterial endotoxin method validation before distributionRecalling firm: Harbin Jixianglong Biotech Co., Ltd.Read what it means & check your lot →Class II2026-01-21TESTO-100 CIII (testosterone 100 mg), 10 Sterile Pellets per carton, RLack of Assurance of Sterility: Potential microbial contamination of subcutaneous pellets.Recalling firm: Advanced Pharmaceutical Technology, Inc.Read what it means & check your lot →Class I2026-01-14CLEARLIFE EXTRA STRENGTHMicrobial Contamination of Non-Sterile Products: The products have been found to contain yeast/mold and microbial contamination identified as Achromobacter.Recalling firm: Medinatura New Mexico, inc.Read what it means & check your lot →Class I2026-01-14REBOOSTMicrobial Contamination of Non-Sterile Products: The products have been found to contain yeast/mold and microbial contamination identified as Achromobacter.Recalling firm: Medinatura New Mexico, inc.Read what it means & check your lot →Class I2025-12-03FAMOTIDINEMicrobial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.Recalling firm: Fresenius Kabi USA, LLCRead what it means & check your lot →Class II2025-12-03Walgreens Saline Nasal Spray WITH XYLITOL, 1.5 oz (45mL) bottle, DISTRMicrobial contamination of a non-sterile product - microorganism found to be pseudomonas lactisRecalling firm: Medical Products Laboratories, Inc.Read what it means & check your lot →Class II2025-10-22Aloe Up Sport Performance Sunscreen Lotion SPF 30, 1 FL OZ (30 mL) percGMP deviations: the firm released and distributed product which failed total aerobic microbial count testing.Recalling firm: SV Labs Prescott CorporationRead what it means & check your lot →Class I2025-10-15NAD+ (Nicotinamide adenine dinucleotide) for Injection, a) 100 mg/mL bMicrobial Contamination of Sterile Products: elevated endotoxin levelsRecalling firm: GenoGenix LLCRead what it means & check your lot →Class I2025-09-10PeriGiene, Health Care Antiseptic, (Chloroxylenol 0.5%) 222 mL (7.5 flMicrobial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.Recalling firm: DermaRite Industries, LLCRead what it means & check your lot →Class I2025-09-10DermaSarra, External Analgesic, (Camphor 0.5%) 222 mL (7.5 fl. oz.) pMicrobial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.Recalling firm: DermaRite Industries, LLCRead what it means & check your lot →Class I2025-09-10DermaKleen, Health Care Antiseptic Lotion Soap with Vitamin E (ChloroxMicrobial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.Recalling firm: DermaRite Industries, LLCRead what it means & check your lot →Class I2025-09-10KleenFoam, Antimicrobial Foam Soap with Aloe Vera, (Chloroxylenol 0.5%Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.Recalling firm: DermaRite Industries, LLCRead what it means & check your lot →Class I2025-07-09Orajel Baby, Cooling Swabs for Teething, Each Unit 0.007 fl oz (0.22 mMicrobial Contamination of Non-Sterile Products: Fungal contamination of infant oral swabs.Recalling firm: Church & Dwight IncRead what it means & check your lot →Class I2025-07-09ZICAM COLD REMEDY MEDICATED NASAL SWABS, 20 Single-Use Swabs per cartoMicrobial Contamination of Non-Sterile Products: Fungal contamination of nasal swabs.Recalling firm: Church & Dwight IncRead what it means & check your lot →Class I2025-07-09ZICAM NASAL ALLCLEAR, 20 Single-Use Swabs per carton, Distributed by Microbial Contamination of Non-Sterile Products: Fungal contamination of nasal swabs.Recalling firm: Church & Dwight IncRead what it means & check your lot →Class I2025-06-18SULFAMETHOXAZOLE AND TRIMETHOPRIMMicrobial contamination of non-sterile products: tablets may exhibit black spots due to microbial contamination.Recalling firm: Amneal Pharmaceuticals, LLCRead what it means & check your lot →Class II2025-04-30HALOPERIDOL DECANOATELack of assurance of sterility. Bacterial contamination detected in some media fill unitsRecalling firm: Amerisource Health Services LLCRead what it means & check your lot →Class II2025-04-30HALOPERIDOL DECANOATELack of assurance of sterility. Bacterial contamination detected in some media fill unitsRecalling firm: Amerisource Health Services LLCRead what it means & check your lot →Class II2025-04-30HALOPERIDOL DECANOATELack of assurance of sterility. Bacterial contamination detected in some media fill unitsRecalling firm: Amerisource Health Services LLCRead what it means & check your lot →Class II2025-04-16HALOPERIDOL DECANOATELack of Assurance of Sterility: Media fill with bacterial contaminationRecalling firm: Somerset Therapeutics Private LimitedRead what it means & check your lot →Class II2025-04-16METHOCARBAMOLLack of Assurance of Sterility: Media fill with bacterial contaminationRecalling firm: Somerset Therapeutics Private LimitedRead what it means & check your lot →Class II2025-04-16HALOPERIDOL DECANOATELack of Assurance of Sterility: Media fill with bacterial contaminationRecalling firm: Somerset Therapeutics Private LimitedRead what it means & check your lot →Class II2025-04-16HALOPERIDOL DECANOATELack of Assurance of Sterility: Media fill with bacterial contaminationRecalling firm: Somerset Therapeutics Private LimitedRead what it means & check your lot →Class II2025-04-16HALOPERIDOL DECANOATELack of Assurance of Sterility: Media fill with bacterial contaminationRecalling firm: Somerset Therapeutics Private LimitedRead what it means & check your lot →Class I2025-04-02SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System (sodium bicarbonMicrobial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureusRecalling firm: Ascent Consumer Products Inc.Read what it means & check your lot →Class I2025-04-02SinuCleanse Soft Tip NETI POT Nasal Wash System (sodium bicarbonate USMicrobial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureusRecalling firm: Ascent Consumer Products Inc.Read what it means & check your lot →Class I2025-04-02SinuCleanse Premixed SALINE PACKETS (sodium bicarbonate USP 700 mg andMicrobial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureusRecalling firm: Ascent Consumer Products Inc.Read what it means & check your lot →Class I2024-10-23ATOVAQUONEMicrobial Contamination of a Non-sterile Product: The product was found to be contaminated with Cohnella bacteria.Recalling firm: Bionpharma Inc.Read what it means & check your lot →Class II2024-10-02SHEET SPF 30 MINERALMicrobial Contamination of Non-Sterile ProductRecalling firm: Vivier Pharma, Inc.Read what it means & check your lot →Class II2024-09-18BARRIER THERAPY SKIN PROTECTANT CREAM (1% colloidal oatmeal), 10 FL OZMicrobial contamination of non-sterile Products -Recalling firm: PREQUEL SKINRead what it means & check your lot →Class I2024-09-11HEPARIN SODIUM IN SODIUM CHLORIDEMicrobial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.Recalling firm: Baxter Healthcare CorporationRead what it means & check your lot →Class II2024-07-24STELLALIFE VEGA ORAL CARE PEPPERMINTMicrobial Contamination of Non-Sterile Products: presence of Terribacillus species organismRecalling firm: Homeocare Laboratories, Inc.Read what it means & check your lot →Class II2024-07-24Oatmeal Daily Moisturizing Body Lotion (1.3% Dimethicone), 8 fl oz (23Microbial Contamination of Non-Sterile Products: confirmed presence of mold contaminationRecalling firm: Brands International CorporationRead what it means & check your lot →Class I2024-07-24STELLALIFE VEGA ORAL CAREMicrobial Contamination of Non-Sterile Products: multiple Bacillus species organismsRecalling firm: Homeocare Laboratories, Inc.Read what it means & check your lot →Class I2024-07-17IMPECCABLE SKIN - IVORYMicrobial Contamination of Non-Sterile Products: Presence of Aspergillus Sydowii (Mold)Recalling firm: SYNCHRONICITY SPA INC, DBA SUNTERead what it means & check your lot →Class II2024-07-10Decitabine for Injection 50mg per vial, For intravenous infusion only CGMP Deviations: Out of Specification for Total Aerobic Microbial Count (TAMC) test for unfiltered bulk for decitabine for injection.Recalling firm: SUN PHARMACEUTICAL INDUSTRIES INCRead what it means & check your lot →Class II2024-06-26LITTLE REMEDIEScGMP deviations: Test results confirmed aypical Burkholderia Cepacia were a result of personnel error.Recalling firm: Denison Pharmaceuticals, LLCRead what it means & check your lot →Class II2024-05-22MAGNESIUM CITRATEMicrobial Contamination of Non-Sterile Products - Presence of Acetobacter nitrogenifigens bacteriaRecalling firm: Pharma Nobis LLCRead what it means & check your lot →Class II2024-05-22MAGNESIUM CITRATEMicrobial Contamination of Non-Sterile Products - Presence of Acetobacter nitrogenifigens bacteriaRecalling firm: Pharma Nobis LLCRead what it means & check your lot →Class I2024-04-24Atovaquone Oral Suspension USP, 750 mg per 5 mL sachets, 20 Units x 5 Microbial contamination of a non-sterile product: potential Bacillus cereus contamination.Recalling firm: AvKARERead what it means & check your lot →Class II2024-03-20FEBUXOSTATCGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.Recalling firm: SUN PHARMACEUTICAL INDUSTRIES INCRead what it means & check your lot →Class II2024-03-20FEBUXOSTATCGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.Recalling firm: SUN PHARMACEUTICAL INDUSTRIES INCRead what it means & check your lot →Class II2024-03-06FLUTICASONE PROPIONATECGMP Deviations:Suspected potential presence of Burkholderia cepacia complexRecalling firm: Golden State Medical Supply Inc.Read what it means & check your lot →Class II2024-02-28FLUTICASONE PROPIONATECGMP Deviations: potential presence of Burkholderia cepacia complexRecalling firm: Apotex Corp.Read what it means & check your lot →Class II2024-01-31LURASIDONE HYDROCHLORIDECGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.Recalling firm: SUN PHARMACEUTICAL INDUSTRIES INCRead what it means & check your lot →Class II2024-01-31ZOLPIDEM TARTRATECGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.Recalling firm: SUN PHARMACEUTICAL INDUSTRIES INCRead what it means & check your lot →Class II2024-01-31MESALAMINECGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.Recalling firm: SUN PHARMACEUTICAL INDUSTRIES INCRead what it means & check your lot →Class I2024-01-31Robitussin Honey CF Max Nighttime Adult (Acetaminophen 650 mg, DiphenhMicrobial Contamination of Non-Sterile ProductsRecalling firm: Haleon US Holdings LLCRead what it means & check your lot →Class II2024-01-31CINACALCETCGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.Recalling firm: SUN PHARMACEUTICAL INDUSTRIES INCRead what it means & check your lot →Class II2024-01-31LURASIDONE HYDROCHLORIDECGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.Recalling firm: SUN PHARMACEUTICAL INDUSTRIES INCRead what it means & check your lot →Class II2024-01-31NIACINCGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.Recalling firm: SUN PHARMACEUTICAL INDUSTRIES INCRead what it means & check your lot →Class II2024-01-31NIACINCGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.Recalling firm: SUN PHARMACEUTICAL INDUSTRIES INCRead what it means & check your lot →Class II2024-01-31FEBUXOSTATCGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.Recalling firm: SUN PHARMACEUTICAL INDUSTRIES INCRead what it means & check your lot →Class I2024-01-31Robitussin Honey CF Max Non-Drowsy Adult (Acetaminophen 650mg, DextromMicrobial Contamination of Non-Sterile ProductsRecalling firm: Haleon US Holdings LLCRead what it means & check your lot →

By cause