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
- impurity
- product-degradation
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.
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