Nelarabine recalls

The FDA has published 2 recalls involving Nelarabine since 2025. The latest was reported on 12 Mar 2025. Most were for potency & assay. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls2since 2025

Last 12 months0reported

Class I00% of total

Ongoing2latest 12 Mar 2025

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 2 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 2 100%Class III 0 0%

Why nelarabine is recalled

Potency & Assay2100%

Companies

Zydus Pharmaceuticals2100%

By year

20252100%

Ongoing nelarabine recalls

2 active

Reported	Class	Recall	Company	Reason	Where
12 Mar 2025Drug	CLASS II	Nelarabine Injection, 250mg/, (5mg/mL) recalledNelarabine	Zydus Pharmaceuticals	Potency & Assay	Nationwide
12 Mar 2025Drug	CLASS II	Nelarabine Injection, 250mg/, (5mg/mL) recalledNelarabine	Zydus Pharmaceuticals	Potency & Assay	Nationwide

All nelarabine recalls, newest first

2 total

Reported	Class	Recall	Company	Reason	Where
12 Mar 2025Drug	CLASS II	Nelarabine Injection, 250mg/, (5mg/mL) recalledNelarabine	Zydus Pharmaceuticals	Potency & Assay	Nationwide
12 Mar 2025Drug	CLASS II	Nelarabine Injection, 250mg/, (5mg/mL) recalledNelarabine	Zydus Pharmaceuticals	Potency & Assay	Nationwide

Should you stop taking Nelarabine?

Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.