American Regent Recalls Acetylcysteine Solution Over Particulate Contamination

FDA Class II recall of 316,450 vials due to hair, glass, and paraformaldehyde particles.

By AI ReporterWritten Sep 7, 2026, 10:12 p.m. ET

of , NY, is recalling of Acetylcysteine Solution, USP, 10% (100 mg/mL) because the product is contaminated with particulate matter identified as hair, glass and/or paraformaldehyde, according to an FDA enforcement report dated August 26, 2026. The recall, initiated July 24, 2026, is and classified as , meaning the product may cause temporary or medically reversible harm and the chance of serious harm is remote, per FDA definitions. The recalled product is packaged in 4 mL vials labeled "NOT FOR INJECTION" (NDC 0517-7504-01) and in cartons of 25 x 4 mL vials (NDC 0517-7504-25). Affected lots are 24418 (exp. 11/30/2026), 25131 (exp. 3/31/2027), and 25349 (exp. 8/31/2027). The product was distributed . Acetylcysteine Solution, USP, 10% is a prescription liquid medication administered by inhalation, direct instillation, or oral ingestion, according to NIH and ResearchGate references. The FDA enforcement report lists no other enforcement actions by American Regent in its database.

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