Zydus Nelarabine Injection Recall: Failed Impurities Risk

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Contact the company & request your remedy

Recalling firmZydus Pharmaceuticals (USA) Inc73 Route 31 N · Pennington, NJ 08534-3601

No email on file — write to the address above instead.

✎ GovInfoNow plain-language explainer

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.

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

Based on the official FDA remedy

What to do — step by step

Contact Healthcare Provider
Patients should speak with their doctor or pharmacist about the recalled product and potential risks.

✎ GovInfoNow

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.

What NDC numbers are affected?

NDC 70710-1839-1 and 70710-1839-8 are affected.

How can I check if I have the recalled product?

Check the product label for the NDC numbers 70710-1839-1 or 70710-1839-8 and expiration dates listed.

Take action

Contact Zydus Pharmaceuticals

We’ve drafted a message you can send Zydus Pharmaceuticals to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall D-0256-2025 — Zydus Pharmaceuticals Zydus Pharmaceuticals

Hello,

I own a Zydus Pharmaceuticals that is covered by recall D-0256-2025 from Zydus Pharmaceuticals.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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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.

Zydus Pharmaceuticals (USA) Inc recalls Nelarabine Injection, 250mg/50mL, (5mg/mL), packaged in: a) 50 mL Single-Dose Vial, NDC 70710-1839-1; b) 6 x 50 mL

Recall notice