FDAClass IIAugust 26, 2026

PEMRYDI RTU(pemetrexed injection) recall

PEMRYDI RTU(pemetrexed injection), 500 mg/50 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: 70121-2461-1

Why was PEMRYDI RTU(pemetrexed injection) recalled?

Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot: P400157, Exp 08/31/2026; Lot PA00047A, Exp 09/30/2027

Product
PEMRYDI RTU(pemetrexed injection), 500 mg/50 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: 70121-2461-1
Recalling firm
Shilpa Medicare Limited
Quantity
9,489 50mL vials
Distribution
Nationwide in the USA.
Recall date
August 26, 2026
Classification
Class II
Status
Ongoing
Agency
FDA (drug)
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