Class II · ModerateActive recall
Nelarabine
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numberLot: a) P300197, Exp. Aug-2025; P400113, Exp. May-26; b) P300169, Exp. Jun-2025; P400115, Exp. May-2026.
Where it was soldUSA Nationwide
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.
What happened
Failed Impurities/Degradation Specifications
What to do
- Check the lot number and expiry on your medicine against the recall above.
- Talk to your pharmacist or doctor before changing anything — don't stop on your own.
- Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).
Who makes it
Made byZydus Lifesciences Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc, Pennington, NJ foreign manufacturer
| Brand name | NELARABINE |
| Generic name | NELARABINE |
| Active ingredient(s) | NELARABINE |
| Distributed by / for | Zydus Pharmaceuticals (USA) Inc, Pennington, NJ |
| NDC | 70710-1839-1 |
Show the full FDA record
| Full product label | 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 |
| Recalling firm | Zydus Pharmaceuticals (USA) Inc |
| Distribution | USA Nationwide |
| Quantity | 1,893 vials |
| Recall initiated | 2025-02-13 |
| Report date | 2025-03-12 |
| Recall completed | — |
| Recall number | D-0256-2025 |
| Classification | Class II |
| FDA status | Ongoing |
| Origin on file | Pennington NJ United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗
This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.