Treprostinil recalls

The FDA has published 2 recalls involving Treprostinil since 2018. The latest was reported on 3 Apr 2024. Par Sterile Products 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 2018

Last 12 months0reported

Class I150% of total

Ongoing1latest 3 Apr 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 treprostinil is recalled

Other Reasons150%
Particulate Matter150%

Companies

Par Sterile Products150%
United Therapeutics150%

By year

2024150%
2018150%

Ongoing treprostinil recalls

1 active

Reported	Class	Recall	Company	Reason	Where
3 Apr 2024Drug	CLASS I	Treprostinil Injection, 20 mg/ (1 mg/mL) recalled	Par Sterile Products	Particulate Matter	Nationwide

All treprostinil recalls, newest first

2 total

Reported	Class	Recall	Company	Reason	Where
3 Apr 2024Drug	CLASS I	Treprostinil Injection, 20 mg/ (1 mg/mL) recalled	Par Sterile Products	Particulate Matter	Nationwide
19 Sep 2018Drug	CLASS III	Tyvaso Inhalation System Patient a) Starter Kit with Tyvaso recalledTyvaso	United Therapeutics	Other	IL, PA

Should you stop taking Treprostinil?

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.