Bleomycin recalls

The FDA has published 2 recalls involving Bleomycin since 2021. The latest was reported on 31 Jan 2024. Most were for labeling errors. Pfizer 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 2021

Last 12 months0reported

Class I150% of total

Ongoing1latest 31 Jan 2024

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 0 0%Class III 1 50%

Why bleomycin is recalled

Labeling Errors150%
Particulate Matter150%

Companies

Pfizer150%
Hikma Pharmaceuticals USA150%

By year

2024150%
2021150%

Ongoing bleomycin recalls

1 active

Reported	Class	Recall	Company	Reason	Where
31 Jan 2024Drug	CLASS I	Bleomycin for Injection, USP per vial dose glass fliptop vial recalledBleomycin	Pfizer	Particulate Matter	Nationwide

All bleomycin recalls, newest first

2 total

Reported	Class	Recall	Company	Reason	Where
31 Jan 2024Drug	CLASS I	Bleomycin for Injection, USP per vial dose glass fliptop vial recalledBleomycin	Pfizer	Particulate Matter	Nationwide
1 Sep 2021Drug	CLASS III	Bleomycin for Injection recalled by Hikma Pharmaceuticals USABleomycin	Hikma Pharmaceuticals USA	Labeling Errors	Nationwide

Should you stop taking Bleomycin?

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.