FDA Drugs recall ·
Nelarabine Injection, 250mg/50mL, (5mg/mL)… recall
- Recall number
- D-0255-2025
- Date
- (initiated February 13, 2025)
- Company / brand
- Zydus Pharmaceuticals (USA) Inc
73 Route 31 N, Pennington, NJ, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 36,978 vials
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Nelarabine Injection, 250mg/50mL, (5mg/mL), packaged in: a) 50 mL Single-Dose Vial, NDC 70710-1726-1; b) 6 x 50 mL Single-Dose Vial, NDC 70710-1726-8, Rx only, Manufactured by Zydus Lifesciences Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc, Pennington, NJ
Why was it recalled?
Failed Impurities/Degradation Specifications
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot: a) P300072, P300073 Exp. Feb-2025; P300153, Exp. Jun-25; P300195, Exp. Aug-2025; P400014, P400017, Exp. Dec-2025; P400070, Exp. Feb-2026; P400112, May-2026; P400142, Exp. Jul-2026; b) P300068, Exp. Feb-2025; P300154, Exp.Jun-2025; P400015, P400018, Exp. Dec-2025; P400068, Exp. Feb-2026; P400114, Exp. May-2026; P400139, Exp.Jul-2026.
Distribution
USA Nationwide
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0255-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.