FDA Closes Class II Recall of PEMRYDI RTU Vials Over Discoloration

The agency considers the recall carried out; affected lots remain identified for anyone still holding the product.

2 reports on this incident · first at Sep 7, 2026, 9:46 p.m. ET

By AI ReporterWritten Sep 7, 2026, 9:54 p.m. ET

The U.S. Food and Drug Administration has closed the recall of PEMRYDI RTU (pemetrexed injection), 500 mg/50 mL (10 mg/mL), single-dose vials, initiated July 29, 2026, according to the agency's enforcement report (recall number ) dated August 26, 2026. Closing the action means the FDA considers the recall carried out. The recall covers 9,489 50 mL vials distributed nationwide, manufactured by Zydus Lifesciences Limited and distributed by Amneal Pharmaceuticals LC. Affected lots are P400157 (exp. 08/31/2026) and PA00047A (exp. 09/30/2027). The firm reported green to dark green discoloration in certain vials. is the FDA's middle category, used where the product may cause temporary or medically reversible harm and where the chance of serious harm is remote, according to the agency's recall definitions. The FDA database records no other enforcement action by , the firm listed for this recall.

Earlier reports

Sep 7, 2026, 9:46 p.m. ETFirst report
FDA Class II Recall Issued for PEMRYDI RTU Vials Due to Discoloration
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for PEMRYDI RTU (pemetrexed injection), 500 mg/50 mL (10 mg/mL), single-dose vials, distributed nationwide. The recall, initiated on July 29, 2026, and reported on August 26, 2026, covers 9,489 vials from lots P400157 (exp. 08/31/2026) and PA00047A (exp. 09/30/2027). The product is manufactured by Zydus Lifesciences Limited, Ahmedabad, India, and distributed by Amneal Pharmaceuticals LC, Bridgewater, NY 08807, under NDC 70121-2461-1.
The recall was prompted by market complaints reporting green to dark green discoloration in certain vials. The FDA classifies this as a Class II recall, meaning the product may cause temporary or medically reversible harm, with the chance of serious harm remote. The recall is ongoing, and the FDA enforcement report lists Shilpa Medicare Limited, Jadcherla, Mahabubnagar District, as the recalling firm.
PEMRYDI RTU is a sterile, ready-to-use liquid prescription drug solution containing pemetrexed, administered intravenously. It is supplied to healthcare facilities and clinical professionals. The FDA database records no other enforcement actions by this firm.

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Version 18 Sept 2026, 01:46current
First published.
Version 18 Sept 2026, 01:54current
First published.

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