Shilpa Medicare Limited PEMRYDI RTU (pemetrexed injection) Recall
Announced 2026-08-26 · FDA
Shilpa Medicare Limited is recalling PEMRYDI RTU pemetrexed injection due to reports of green to dark green discoloration in some vials. About 9,489 50 mL vials distributed nationwide in the United States are affected. Affected lots are P400157 (exp 08/31/2026) and PA00047A (exp 09/30/2027).
| Brand | Shilpa Medicare Limited |
|---|---|
| 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 |
| Reason | Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials |
| Severity | moderate |
| Units affected | 18434 |
| Distribution | Nationwide in the USA. |
| Agency | FDA |
WHAT YOU SHOULD DO
- Check if your PEMRYDI RTU vials are from lot P400157 or PA00047A.
- Do not use any vial showing green or dark green discoloration and set it aside.
- Contact your healthcare provider or pharmacist for guidance on replacement or return of the recalled product.
- Dispose of any affected vials according to your healthcare provider’s instructions or local disposal guidelines.
How to identify the recalled item
| Lot / date codes | Lot: P400157, Exp 08/31/2026; Lot PA00047A, Exp 09/30/2027 |
|---|---|
| Lot / date codes | Lot: P400172; Lot PA00050A, Exp 09/30/2027 |
These are the identifiers FDA published for this recall. Most recall notices list no UPC or model number at all — if the code on your item is not shown here, that does not mean the item is excluded. Check the official notice, or contact the company.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.