Sterility concerns drugs recalls
18 FDA Class I drugs recall events since Jan 1, 2025 whose stated reason matches “Sterility concerns”. Grouping is by keyword in FDA's reason text — see methodology.
Recalls
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Greenwich Rx drug recall: Glutathione Injection
Microbial Contamination of Sterile Products
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American Regent, Inc. drug recall: Epinephrine Injection
Presence of Particulate Matter and Lack of Assurance of Sterility. Particulate matter identified as nylon, cellulosic, acrylic, polyethylene and glass and broken and…
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Optimal Balance Pharmacy drug recall: Glutathione 200 mg/mL
Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.
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Victory Medical Center Pharmacy drug recall: Glutathione
Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.
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Blaine Labs Inc drug recall: Revitaderm Wound Care Gel
Microbial contamination of Non-Sterile Product: samples identified the presence of Lysinibacillus fusiformis and other Bacillus spp
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CareFusion 213, LLC drug recall: BD ChloraPrep Clear
Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.
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Beekeeper's Naturals USA Inc. drug recall: BEEKEEPER'S NATURALS Saline Nasal Spray
Microbial Contamination of Non-Sterile Products
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Wisconsin Pharmacal Company drug recall: MG217 Multi-Symptom Treatment Cream & Skin Protectant
Microbial Contamination of Non-Sterile Products: confirmed presence of Staphylococcus Aureus.
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Cardinal Health 200, LLC drug recall: Webcol Alcohol Prep pad
Non-Sterility: microbial contamination identified as Paenibacillus phoenicis
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Medinatura New Mexico, inc. drug recall: ReBoost Nasal Spray
Microbial Contamination of Non-Sterile Products: The products have been found to contain yeast/mold and microbial contamination identified as Achromobacter.
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Fresenius Kabi USA, LLC drug recall: Famotidine Injection
Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
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GenoGenix LLC drug recall: Alpha Lipoic Acid for Injection
Lack of Assurance of Sterility
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DermaRite Industries, LLC drug recall: DermaKleen
Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated with the bacteria Burkholderia cepecia.
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Church & Dwight Inc drug recall: Zicam Cold Remedy Medicated Nasal Swabs
Microbial Contamination of Non-Sterile Products: Fungal contamination of nasal swabs.
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Amneal Pharmaceuticals, LLC drug recall: Sulfamethoxazole and Trimethoprim Tablets
Microbial contamination of non-sterile products: tablets may exhibit black spots due to microbial contamination.
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Ascent Consumer Products Inc. drug recall: SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System
Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus
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CareFusion 213, LLC drug recall: BD ChloraPrep Clear 1mL Applicators
Non-Sterility: contamination of Aspergillus penicillioides, due to breach in package lidding.
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Alcon Research LLC drug recall: Systane Lubricant Eye Drops
Non-Sterility