D-0765-2026 Class II Ongoing
FDA drug recall D-0765-2026 was initiated by Shilpa Medicare Limited on July 29, 2026 and is designated Class II. Reason for recall: Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials The recall status is ongoing. Affected quantity: 9,489 50mL vials.
Recall Details
- Product Type
- Drugs
- Report Date
- August 26, 2026
- Initiation Date
- July 29, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9,489 50mL 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
Reason for Recall
Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials
Distribution Pattern
Nationwide in the USA.
Code Information
Lot: P400157, Exp 08/31/2026; Lot PA00047A, Exp 09/30/2027