Home / Recalls / Zydus Pharmaceuticals (USA) Inc / D-0255-2025

D-0255-2025 Class II Ongoing

Recalled by Zydus Pharmaceuticals (USA) Inc — Pennington, NJ

Recall Details

Product Type
Drugs
Report Date
March 12, 2025
Initiation Date
February 13, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
36,978 vials

Product Description

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

Reason for Recall

Failed Impurities/Degradation Specifications

Distribution Pattern

USA Nationwide

Code Information

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.

Other recalls by Zydus Pharmaceuticals (USA) Inc

  • D-0400-2026 Class II — Icosapent Ethyl Capsules, 1 gram, 120 Capsules per bottle, Rx only, Manufactured (March 9, 2026)
  • D-0295-2026 Class II — Icosapent Ethyl capsules, 1 gram, 120-count bottles, Rx only, Manufactured by: S (December 30, 2025)
  • D-0247-2026 Class III — traZODONE Hydrochloride Tablets, USP, 100mg, 1,000 Tablets, Rx only, Manufacture (December 19, 2025)
  • D-0159-2026 Class II — Bromocriptine Mesylate Capsules, USP, 5 mg, 30 Capsules per bottle, Rx Only. Man (October 23, 2025)
  • D-0154-2026 Class II — clomiPRAMINE Hydrochloride, Capsules, USP, 75 mg, packaged in a) 30-count bottle (October 22, 2025)
  • D-0152-2026 Class II — clomiPRAMINE Hydrochloride, Capsules, USP, 25 mg, packaged in a) 30-count bottle (October 22, 2025)
  • D-0153-2026 Class II — clomiPRAMINE Hydrochloride, Capsules, USP, 50 mg, packaged in a) 30-count bottle (October 22, 2025)
  • D-0001-2026 Class II — Entecavir Tablets, USP, 0.5 mg, 30-count bottle, Rx Only, Manufactured by: Zydus (September 24, 2025)
  • D-0002-2026 Class II — Entecavir Tablets, USP, 1 mg, 30-count bottle, Rx Only, Manufactured by: Zydus L (September 24, 2025)
  • D-0657-2025 Class II — Entecavir Tablets, USP, 1 mg, 30 Tablets, Rx Only, Manufactured by: Zydus Lifesc (September 4, 2025)