FDA Drug recall D-0765-2026
PEMRYDI RTU(pemetrexed injection), 500 mg/50 mL (10 mg/mL), Single-dose vial, Rx only, Manufactured by: Zydus Lifesciences Limited, Ahmedab…
- FDA Drug
- Class II
- ongoing
- Published 2026-08-26
On 2026-08-26 the FDA classified a Class II recall of PEMRYDI RTU(pemetrexed injection), 500 mg/50 mL (10 mg/mL), Single-dose vial, Rx only, Manufactured by: Zydus Lifesciences Limited, Ahmedab… by Shilpa Medicare, citing discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0765-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-07-29 |
| Published | 2026-08-26 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Shilpa Medicare |
| Distribution | US |
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
Identifiers
| ndc | 70121-2453-1 |
|---|---|
| ndc | 70121-2461-1 |
| ndc | 70121-2462-1 |
| code_info | Lot: P400157, Exp 08/31/2026; Lot PA00047A, Exp 09/30/2027 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Other recalls by Shilpa Medicare
- PEMRYDI RTU (pemetrexed injection), 100 mg/10 mL (10 mg/mL), Single-dose vial, Rx only, Manufactured by: Zydus Lifesciences Limited, Ahmeda…
FDA Drug · Class II · 2026-08-26 · Shilpa Medicare - Azacitidine for Injection 100 mg/vial, For Subcutaneous and Intravenous Use Only, Rx Only, One Single Dose Vial, Cytotoxic Agent, Manufactu…
FDA Drug · Class II · 2020-12-16 · Shilpa Medicare - Imatinib Mesylate Tablets 100 mg, Rx Only, 90-count Bottle, Manufactured by: Shilpa Medicare Limited, India, Distributed by: Armas Pharmace…
FDA Drug · Class II · 2020-12-16 · Shilpa Medicare - Imatinib Mesylate Tablets 400 mg, Rx Only, 30-count Bottle, Manufactured by: Shilpa Medicare Limited, India, Distributed by: Armas Pharmace…
FDA Drug · Class II · 2020-12-16 · Shilpa Medicare - Azacitidine for Injection 100 mg/vial, For Subcutaneous and Intravenous Use Only, Rx Only, One Single Dose Vial, Cytotoxic Agent, Manufactu…
FDA Drug · Class II · 2020-12-16 · Shilpa Medicare
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0765-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.