Nelarabine Injection Recalled Due to Impurity and Degradation Concerns

Zydus Pharmaceuticals (USA) Inc. has issued a nationwide voluntary recall of nelarabine injection, 250 mg/50 mL (5 mg/mL), citing failed impurities and degradation specifications as the reason for withdrawal. The recall affects 2 sets of products, with a total of 38,871 vials manufactured by Zydus Lifesciences Ltd. in Ahmedabad, India. The impacted lot numbers include P300072, P300073, P300153, P300195, P400014, P400017, P400070, P400112, P400142, among others, with expiration dates ranging from February 2025 to July 2026. The recall was initiated on February 13, 2025, and classified as Class II by the US Food and Drug Administration (FDA), meaning that the defective product may cause temporary or medically reversible adverse health effects.

The recall applies to both single-dose 50 mL vials and 6-pack 50 mL vials, distributed under 2 different NDC numbers (70710-1726 and 70710-1839). The affected lots were distributed across the US, and customers were notified via letter. While no adverse events have been reported, pharmacists and health care providers are advised to immediately stop dispensing the affected product and return it per the recall instructions. The recall remains ongoing, and no public press release has been issued.

Nelarabine injection is a chemotherapy agent indicated for the treatment of T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) in patients who have relapsed or are refractory to at least 2 prior chemotherapy regimens. Given its critical role in treating these aggressive hematologic malignancies, pharmacists should verify inventory and seek alternative supplies to avoid disruptions in patient care. Any adverse reactions or quality concerns should be reported to the FDA MedWatch program.