Alprostadil recalls

The FDA has published 4 recalls involving Alprostadil since 2017. The latest was reported on 15 Jun 2022. Most were for potency & assay. Teva Pharmaceuticals U 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 2017

Last 12 months0reported

Class I00% of total

Ongoing0latest 15 Jun 2022

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 75%Class III 1 25%

Why alprostadil is recalled

Potency & Assay250%
Sterility250%

Companies

By year

2022125%
2021125%
2018125%
2017125%

All alprostadil recalls, newest first

4 total

Reported	Class	Recall	Company	Reason	Where
15 Jun 2022Drug	CLASS III	Alprostadil Injection USP 500 mcg/mL Single Dose Vial, 5 vials recalled	Teva Pharmaceuticals USA	Potency & Assay	Nationwide
25 Aug 2021Drug	CLASS II	Alprostadil Injection USP, 500 mg/mL single dose recalled	Teva Pharmaceuticals U	Sterility	Nationwide
21 Nov 2018Drug	CLASS II	Alprostadil Injection USP 500 micrograms/mL single use vial recalled	Teva Pharmaceuticals U	Potency & Assay	Nationwide
15 Mar 2017Drug	CLASS II	Edex (alprostadil for injection) 10mcg recalled by Endo PharmaceuticalsEdex	Endo Pharmaceuticals	Sterility	Nationwide

Should you stop taking Alprostadil?

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.