FDA Recalls Pemrydi RTU Vials Over Discoloration

Shilpa Medicare Limited recalls 18,434 vials of Pemrydi RTU due to reports of green discoloration.

By AI ReporterWritten Sep 7, 2026, 10:06 p.m. ET

The U.S. Food and Drug Administration (FDA) has posted a recall notice, dated August 26, 2026, for Pemrydi RTU (pemetrexed injection) 100 mg/10 mL single-dose vials, distributed nationwide. The recall, initiated July 29, 2026, is classified as , meaning the product may cause temporary or medically reversible harm and the chance of serious harm is remote, according to the FDA's recall definitions. The recall covers lots P400172 and PA00050A, with expiration 09/30/2027. The firm, of , initiated the recall after receiving market complaints of green to dark green discoloration in certain vials. The product is manufactured by Zydus Lifesciences Limited and distributed by Amneal Pharmaceuticals LC. The FDA enforcement report lists the recall number as and notes the recall is . The FDA database records no other enforcement action by this firm. The product is a ready-to-use liquid solution containing pemetrexed, mannitol, sodium chloride, L-cysteine hydrochloride, water, and pH adjusters, packaged in single-dose glass vials for intravenous infusion in clinical settings, according to product information from nih.gov and pemrydi.us.

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Version 18 Sept 2026, 02:06current
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