The Recall Desk
HighFDA (Drugs)·D-0255-2025·Announced 2025-03-12

Prescription Nelarabine Injection Recalled for Failed Purity and Degradation Specifications

Zydus Pharmaceuticals is recalling nationwide lots of Nelarabine Injection, a cancer medication, due to failed purity and degradation specifications. The affected vials did not meet required quality standards.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II drug recall with no reported illnesses or injuries. Per the severity rubric, risk-of-harm products where injury has not yet been reported receive a High rating. Nelarabine is a serious-disease medication used in cancer treatment; the manufacturing defect affects pharmaceutical purity, which is critical for drug safety.

Plain-English summary

Zydus Pharmaceuticals (USA) Inc is recalling Nelarabine Injection, an intravenous cancer medication, due to failed impurities and degradation specifications. The recall affects approximately 36,978 vials distributed nationwide.

Nelarabine is used to treat certain blood cancers. The recall applies to multiple lot numbers of both single-dose vials and multi-pack vials with various expiration dates ranging from February 2025 through July 2026.

Patients currently receiving treatment and healthcare providers should contact Zydus Pharmaceuticals or consult their healthcare provider regarding their medication. The FDA classified this as a Class II recall, indicating the product could cause adverse health consequences.

The recalled product

Product
NELARABINE (NELARABINE)
Brand
NELARABINE
Manufacturer
Zydus Pharmaceuticals (USA) Inc
Category
Drug — Oncology / Injectable
Hazard
Affected units
36,978

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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

UPCs (1)

  • 0370710172619

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Zydus Pharmaceuticals (USA) Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same brand · NELARABINE

Same manufacturer · Zydus Pharmaceuticals (USA) Inc

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Same hazard · impurity

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