FDA Recall D-0255-2025

Zydus Pharmaceuticals (USA) Inc · Pennington, NJ

Class II Ongoing 455 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

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

Lot / code: 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.

Quantity: 36,978 vials

Reason for recall

Failed Impurities/Degradation Specifications

Recall record

Recall number: D-0255-2025
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: USA Nationwide
Recall initiated: 2025-02-13
Classified by FDA Center: 2025-03-06
FDA published: 2025-03-12
Recalling firm: Zydus Pharmaceuticals (USA) Inc
Firm location: Pennington, NJ

Drug identification

Brand name(s): NELARABINE
Generic name(s): NELARABINE
Manufacturer(s): Zydus Pharmaceuticals USA Inc.
NDC(s): 70710-1726
Route(s): INTRAVENOUS

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

‹ All recalls