Cytarabine recalls

The FDA has published 4 recalls involving Cytarabine since 2012. The latest was reported on 21 Aug 2019. Most were for particulate matter. Infusion Options has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls4since 2012

Last 12 months0reported

Class I125% of total

Ongoing0latest 21 Aug 2019

Recalls per month, last 24 months

click a bar for that month

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

Severity split

Class I 1 25%Class II 3 75%Class III 0 0%

Why cytarabine is recalled

Particulate Matter250%
Sterility250%

Companies

By year

2019125%
2015125%
2014125%
2012125%

All cytarabine recalls, newest first

4 total

Reported	Class	Recall	Company	Reason	Where
21 Aug 2019Drug	CLASS II	Cytarabine 128 MG/ D5W IVPB recalled by Infusion Options	Infusion Options	Sterility	NY
19 Aug 2015Drug	CLASS I	Cytarabine Injection 100 mg/ (20 mg/mL) Single-Dose Vial recalled	Mylan Institutional	Particulate Matter	Nationwide
27 Aug 2014Drug	CLASS II	CYTARAbine for Injection USP, lyophiled in glass vials per vial recalled	Ben Venue Laboratories	Sterility	Nationwide
26 Sep 2012Drug	CLASS II	Cytarabine Injection, 20 mg/mL Single Dose Vial recalled by HospiraCytarabine	Hospira	Particulate Matter	Nationwide

Should you stop taking Cytarabine?

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.