Nelarabine Injection — Class II drug recall D-0256-2025
Ongoing recall by Zydus Pharmaceuticals (USA) Inc, reported 2025-03-12, distributed nationwide. Failed Impurities/Degradation Specifications
| Recall number | D-0256-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zydus Pharmaceuticals (USA) Inc, Pennington, NJ, United States |
| Recall initiated | 2025-02-13 |
| Classified | 2025-03-06 |
| Reported by FDA | 2025-03-12 |
| Distributed | Nationwide (US) |
| Quantity | 1,893 vials |
| Reason classes | specification failure |
| NDC | 70710-1839, 70710-1839-01, 70710-1839-08 |
Product
Nelarabine Injection, 250mg/50mL, (5mg/mL), packaged in: a) 50 mL Single-Dose Vial, NDC 70710-1839-1; b) 6 x 50 mL Single-Dose Vial, NDC 70710-1839-8, Rx only, Manufactured by Zydus Lifesciences Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc, Pennington, NJ
Reason for recall
Failed Impurities/Degradation Specifications
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-0256-2025. 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.