← FDA ENFORCEMENT
D-0765-2026Class II

Shilpa Medicare Limited

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
Shilpa Medicare Limited
Product type
Drug
Status
Ongoing
Report date
2026-08-26
Distribution
Nationwide in the USA.
Product quantity
9,489 50mL vials
Initiated by
Voluntary: Firm initiated
Reason for recall

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

Product description

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

Code / lot info

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

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →