Epoprostenol recalls

The FDA has published 3 recalls involving Epoprostenol since 2021. The latest was reported on 25 Aug 2021. Most were for sterility. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls3since 2021

Last 12 months0reported

Class I00% of total

Ongoing0latest 25 Aug 2021

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 0 0%Class II 3 100%Class III 0 0%

Why epoprostenol is recalled

Sterility3100%

Companies

Teva Pharmaceuticals U3100%

By year

20213100%

All epoprostenol recalls, newest first

3 total

Reported	Class	Recall	Company	Reason	Where
25 Aug 2021Drug	CLASS II	Epoprostenol Sodium for Injection, 5 mg/vial vials recalled	Teva Pharmaceuticals U	Sterility	Nationwide
3 Mar 2021Drug	CLASS II	Epoprostenol Sodium for Injection, 5 mg/vial (500,000 ng) recalled	Teva Pharmaceuticals U	Sterility	Nationwide
3 Mar 2021Drug	CLASS II	Epoprostenol Sodium for Injection, 5 mg/vial (1,500,000 ng) vial recalled	Teva Pharmaceuticals U	Sterility	Nationwide

Should you stop taking Epoprostenol?

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.