CLASS II ONGOING Drug recall · Reported 12 Mar 2025 · FDA Enforcement Report
Nelarabine Injection, 250mg/, (5mg/mL) recalled
Zydus Pharmaceuticals is recalling Nelarabine Injection, 250mg/, (5mg/mL), distributed nationwide in the US. The recall was initiated on 13 Feb 2025 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0256-2025
- FDA event ID
- 96291
- Recalling firm
- Zydus Pharmaceuticals, Pennington, NJ
- Brand
- Nelarabine
- Manufacturer
- Zydus Pharmaceuticals USA Inc.
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 13 Feb 2025
- FDA classified
- 6 Mar 2025
- Reported
- 12 Mar 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Injectable & IV Drugs
Timeline
| 13 Feb 2025 | Recall initiated by company | |
| 6 Mar 2025 | Classified by FDA | +21 days |
| 12 Mar 2025 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Impurities/Degradation Specifications
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
USA Nationwide
Questions about this recall
Why was it recalled?
Failed Impurities/Degradation Specifications
Which lots are affected?
Lot: a) P300197, Exp. Aug-2025; P400113, Exp. May-26; b) P300169, Exp. Jun-2025; P400115, Exp. May-2026.
Where was it sold?
USA Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 96291| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Nelarabine Injection, 250mg/, (5mg/mL) recalledNelarabine | Zydus Pharmaceuticals | Potency & Assay | Nationwide |
More recalls from Zydus Pharmaceuticals
All 54| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Mirabegron Extended-Release Tablets, 25 mg recalledMirabegron | Zydus Pharmaceuticals | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Erythromycin Tablets, USP, 250 mg recalledErythromycin | Zydus Pharmaceuticals | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Erythromycin Tablets, USP, 500 mg recalledErythromycin | Zydus Pharmaceuticals | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Icosapent Ethyl Capsules recalled by Zydus Pharmaceuticals (USA)Icosapent Ethyl | Zydus Pharmaceuticals | Other | Nationwide |
| Drug | CLASS II | Icosapent Ethyl capsules recalled by Zydus Pharmaceuticals (USA) | Zydus Pharmaceuticals | Potency & Assay | Nationwide |
Other Nelarabine recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Nelarabine Injection, 250mg/, (5mg/mL) recalledNelarabine | Zydus Pharmaceuticals | Potency & Assay | Nationwide |