PEMRYDI RTU (pemetrexed injection), 100 mg/10 mL (10… was recalled on July 29, 2026 in cooperation with the U.S. Food and Drug Administration because discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials.
PEMRYDI RTU (pemetrexed injection), 100 mg/10 mL (10 mg/mL), Single-dose vial, Rx only, Manufactured by: Zydus Lifesciences Limited, Ahmedabad, India; Distributed by: Amneal Pharmaceuticals LC, Bridgewater, NY 08807. NDC: 70121-2453-1
Lot: P400172; Lot PA00050A, Exp 09/30/2027
Units affected: 18,434 10mL vials
Where it was sold: Nationwide in the USA.
Compare the codes above against the label on your product — usually on the bottom, the back panel, or the packaging. If your unit isn't listed, it is not part of this recall.
Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials
Class II means the product might cause a temporary or medically reversible health problem; the chance of serious harm is remote.
Stop using the product. Return it to the place of purchase for a refund, or dispose of it. Contact the recalling firm with questions.
Contact: Recalling firm: Shilpa Medicare Limited
Not sure what you're entitled to? Read our guide: what to do if your product is recalled.
Always confirm details on the official notice from the U.S. Food and Drug Administration before acting.
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Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU).
Potential foreign object contamination: rubber pieces
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