Zydus Nelarabine Injection Recall: Failed Impurities Risk
Zydus Pharmaceuticals recalls Nelarabine injection due to failed impurities and degradation. This medication, used for cancer treatment, may have harmful substances that could cause serious health issues if used.
Recall notice
Failed Impurities/Degradation Specifications
Contact the company
What happened, in plain English
Zydus Pharmaceuticals is recalling Nelarabine injection products that may contain impurities or degrade, which could lead to serious health risks. Patients using this medication should contact their healthcare provider for guidance. Read more at govinfonow.com/recall/32283-zydus-nelarabine-injection-recall-failed-impurities-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/32283-zydus-nelarabine-injection-recall-failed-impurities-risk · Updated August 17, 2026 · FDA enforcement record: FDA #D-0256-2025
Cite this page
“Zydus Nelarabine Injection Recall: Failed Impurities Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/32283-zydus-nelarabine-injection-recall-failed-impurities-risk. Based on FDA recall #D-0256-2025 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0256-2025%22&limit=1).
Why it’s dangerous
The injection may contain impurities or degrade over time, potentially causing harmful substances that could lead to serious health issues. This is a medication used for cancer treatment, so the risks are significant.
Who’s affected
Patients prescribed Nelarabine injection for cancer treatment. Those using the specific product with the listed NDC numbers and expiration dates are most at risk.
How to tell if you have this one
Check for the product name 'Nelarabine Injection, 250mg/50mL (5mg/mL)' with NDC numbers 70710-1839-1 or 70710-1839-8. The expiration dates listed are August 2025, May 2026, and June 2025.
- Brand
Zydus Pharmaceuticals- Category
Drug
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
USA Nationwide
| Recall number | Product, codes & lots | Quantity | NDC |
|---|---|---|---|
| D-0255-2025 | 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; 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. | 36,978 vials | 70710-1726-1, 70710-1726-8 |
| D-0256-2025 | Nelarabine Injection, 250mg/50mL, (5mg/mL), packaged in: a) 50 mL Single-Dose Vial, NDC 70710-1839-1; b) 6 x 50 mL Single-Dose Vial, NDC 70710-1839-8, Rx only, Manufactured by Zydus Lifesciences Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc, Pennington, NJ; Lot: a) P300197, Exp. Aug-2025; P400113, Exp. May-26; b) P300169, Exp. Jun-2025; P400115, Exp. May-2026. | 1,893 vials | 70710-1839-1, 70710-1839-8 |
What to do — step by step
Contact Healthcare Provider
Patients should speak with their doctor or pharmacist about the recalled product and potential risks.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “USA Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 27 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Questions people ask
Is this product safe to use?
The recall indicates potential impurities or degradation, so it is not safe to use without consulting a healthcare provider.
Similar recalls
Other Zydus Pharmaceuticals recalls
Latest drug recalls
Keep exploring
Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0256-2025 (February 13, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0256-2025 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.