PEMRYDI RTU — Class II drug recall D-0764-2026
Ongoing recall by Shilpa Medicare Limited, reported 2026-08-26, distributed nationwide. Discolored solution. The firm has received market complaints reporting green to dark green discoloration in ce
| Recall number | D-0764-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Shilpa Medicare Limited, Jadcherla, Mahabubnagar District, India |
| Recall initiated | 2026-07-29 |
| Classified | 2026-08-14 |
| Reported by FDA | 2026-08-26 |
| Distributed | Nationwide (US) |
| Quantity | 18,434 |
| NDC | 70121-2453, 70121-2453-01, 70121-2461, 70121-2461-01, 70121-2462, 70121-2462-01 |
| Lot numbers | P400172, PA00050A |
| Expiration dates | 2027-09-30 |
Product
PEMRYDI RTU (pemetrexed injection), 100 mg/10 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: 70121-2453-1
Reason for recall
Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0764-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.