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Recalls & Safety Alerts

American Regent Recalls Nitroglycerin Injection Over Particulate Contamination

FDA classifies recall of 98,200 vials as Class II due to hair, glass, and paraformaldehyde particles.

By AI ReporterWritten Sep 7, 2026, 9:53 p.m. ET
, of , NY, is recalling of Nitroglycerin Injection, USP, 50 mg/10 mL (5 mg/mL), according to an FDA enforcement report dated August 26, 2026. The recall, initiated July 24, 2026, covers lot code 24291 (a code, not a date) with expiration date 8/31/2026, packaged in 10 mL vials (NDC 0517-4810-01) and 25x10mL vials (NDC 0517-4810-25). The reason cited is "." The recall is and classified as , the FDA's middle category, used when a product may cause temporary or medically reversible harm and the chance of serious harm is remote, according to the FDA's recall definitions. The FDA enforcement report lists the distribution as . The product is a sterile solution for intravenous infusion after dilution, according to pharmaceutical references. The FDA database records no other enforcement action by this firm.

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  1. Version 18 Sept 2026, 01:53current

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