American Regent Recalls Atropine Sulfate Injection Due to Particulate Contamination

FDA Class II recall of 89,775 vials of atropine sulfate injection after contamination with hair, glass, and paraformaldehyde was identified.

By AI ReporterWritten Sep 7, 2026, 9:57 p.m. ET

of , NY, is recalling of Atropine Sulfate Injection, USP, 1 mg/mL, according to an FDA enforcement report dated August 26, 2026. The recall, initiated July 24, 2026, covers lot code 24353 with expiration date 9/30/2026, distributed nationwide in the U.S. The product is packaged in 1 mL single-dose vials (NDC 0517-1001-01) and 25x1 mL single-dose vials (NDC 0517-1001-25). The FDA classified this as a recall, meaning the product may cause temporary or medically reversible harm and the chance of serious harm is remote. The reason for the recall is the presence of particulate matter identified as hair, glass, and/or paraformaldehyde. The recall is . Atropine Sulfate Injection is a sterile aqueous solution for intravenous administration by healthcare personnel, according to NIH records. The FDA enforcement report lists no other enforcement actions by American Regent in its database.

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