Nelarabine prescription injection recalled due to failed quality specifications
Zydus Pharmaceuticals is recalling 1,893 vials of Nelarabine Injection (250 mg/50 mL) due to failed quality specifications for impurities and degradation. Patients should contact their healthcare provider about the recall.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: FDA Class II recall of an injectable prescription medication with failed impurity and degradation specifications. Though no illnesses have been reported, quality failures in pharmaceutical products present a potential risk of harm and exceed the threshold for Class III recalls.
Plain-English summary
Zydus Pharmaceuticals (USA) Inc is recalling Nelarabine Injection, 250 mg per 50 mL vials, due to failed quality specifications related to impurities and degradation limits.
The affected product consists of 1,893 vials across multiple lot numbers with varying expiration dates. The medication failed to meet established specifications for impurity content and product degradation, which are critical quality parameters for pharmaceutical products.
The recalled product was distributed nationwide in the United States. This is a prescription injectable medication.
Patients currently taking Nelarabine Injection should not discontinue treatment without consulting their healthcare provider about the recall and their specific situation. Healthcare providers should check whether their inventory includes any of the affected lot numbers and contact Zydus Pharmaceuticals (USA) Inc or the FDA for guidance on handling and return procedures.
The recalled product
- Product
- NELARABINE (NELARABINE)
- Brand
- NELARABINE
- Manufacturer
- Zydus Pharmaceuticals (USA) Inc
- Category
- Drug — Prescription injectable
- Hazard
- Affected units
- 1,893
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 (8)
- Lot: a) P300197
- Exp. Aug-2025
- P400113
- Exp. May-26
- b) P300169
- Exp. Jun-2025
- P400115
- Exp. May-2026.
UPCs (1)
- 0370710183912
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
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