Reported Mar 12, 2025 · Ongoing

Nelarabine Injection, 250mg/50mL, (5mg/mL), packaged in: a) 50 mL Single-Dose Vial, NDC 70710-1726-1; b) 6 x 50 mL…

Zydus Pharmaceuticals (USA) Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Zydus Pharmaceuticals (USA) Inc · 73 Route 31 N · Pennington, NJ · 08534-3601

- Nelarabine Injection
- 250mg/50mL
- (5mg/mL)
packaged ina) 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 byZydus Pharmaceuticals (USA) Inc, Pennington, NJ

Lot codes and dates: 13 of 13 products
Products covered by this recall
# Product as published
1 Lot: a) P300072, P300073 Exp. Feb-2025
2 P300153, Exp. Jun-25
3 P300195, Exp. Aug-2025
4 P400014, P400017, Exp. Dec-2025
5 P400070, Exp. Feb-2026
6 P400112, May-2026
7 P400142, Exp. Jul-2026
8 P300068, Exp. Feb-2025
9 P300154, Exp.Jun-2025
10 P400015, P400018, Exp. Dec-2025
11 P400068, Exp. Feb-2026
12 P400114, Exp. May-2026
13 P400139, Exp.Jul-2026.
Amount recalled: 36,978 vials

The agency filed one notice per product. You are reading one of them; the other one is below.

Failed Impurities/Degradation Specifications

This product could cause temporary or reversible health problems — stop using it.

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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26 in total.