Foreign material drugs recalls
6 FDA Class I drugs recall events since Jan 1, 2025 whose stated reason matches “Foreign material”. Grouping is by keyword in FDA's reason text — see methodology.
Recalls
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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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Baxter Healthcare Corporation drug recall: 0.9% Sodium Chloride Injection USP 500 mL
Presence of particulate matter: Particulates identified as fiberglass
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Fresenius Kabi USA, LLC drug recall: Tyenne
Presence of particulate matter:An internal investigation at the firm found the product to contain glass particles.
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American Regent, Inc. drug recall: Nitroglycerin injection
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
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Liebel-Flarsheim Company LLC drug recall: Optiray Imaging Bulk Package-350
Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass.
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Sun Pharmaceutical Industries Inc drug recall: DOXOrubin Hydrochloride Liposome injection
Presence of Particulate matter: Particulate matter identified as glass.