Topotecan recalls

The FDA has published 2 recalls involving Topotecan since 2019. The latest was reported on 14 Jul 2021. Most were for sterility. Teva Pharmaceuticals USA 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 recalls2since 2019

Last 12 months0reported

Class I150% of total

Ongoing0latest 14 Jul 2021

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 0 0 0May 0 0 0Aug 0 0 0Nov 0 0 0Feb 0 0 0May 0 0 0Aug 0 0

Severity split

Class I 1 50%Class II 1 50%Class III 0 0%

Why topotecan is recalled

Sterility150%
Particulate Matter150%

Companies

Teva Pharmaceuticals USA150%
Infusion Options150%

By year

2021150%
2019150%

All topotecan recalls, newest first

2 total

Reported	Class	Recall	Company	Reason	Where
14 Jul 2021Drug	CLASS I	Topotecan Injection 4 mg/ (1 mg/mL), Single-Dose vial recalled	Teva Pharmaceuticals USA	Particulate Matter	Nationwide
21 Aug 2019Drug	CLASS II	Topotecan 1.24 MG / Ns Ivpb recalled by Infusion Options	Infusion Options	Sterility	NY

Should you stop taking Topotecan?

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.