Alprostadil recalls

The FDA has published 41 recalls involving Alprostadil since 2012. The latest was reported on 20 Jul 2022. Most were for sterility. Vita Pharmacy 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 recalls41since 2012

Last 12 months0reported

Class I00% of total

Ongoing2latest 20 Jul 2022

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 0 0%Class II 40 98%Class III 1 2%

Why alprostadil is recalled

Companies

By year

202225%
2021820%
2020717%
201912%
201825%
201737%
2015820%
201425%
2013717%
201212%

Ongoing alprostadil recalls

2 active

Reported	Class	Recall	Company	Reason	Where
20 Jul 2022Drug	CLASS II	Alprostadil/Papaverine/Phentolamine 60mcg/30mg/3mg/mL-vial recalled	TMC Acquisition	Sterility	Nationwide
17 Jul 2013Drug	CLASS II	Alprostadil 2000 mcg/ml, compounded by Olympia Pharmacy, Orlando, FL recalled	Lowlite Investments	Sterility	Nationwide

All alprostadil recalls, newest first

41 total

Reported	Class	Recall	Company	Reason	Where
20 Jul 2022Drug	CLASS II	Alprostadil/Papaverine/Phentolamine 60mcg/30mg/3mg/mL-vial recalled	TMC Acquisition	Sterility	Nationwide
15 Jun 2022Drug	CLASS III	Alprostadil Injection USP 500 mcg/mL Single Dose Vial, 5 vials recalled	Teva Pharmaceuticals USA	Potency & Assay	Nationwide
17 Nov 2021Drug	CLASS II	Alprostadil 25mcg/ML 25mcg/ML Injectable recalled by Vita Pharmacy	Vita Pharmacy	Sterility	DC, PR
17 Nov 2021Drug	CLASS II	Alprostadil 32mcg/ML 32mcg/ML Injectable recalled by Vita Pharmacy	Vita Pharmacy	Sterility	DC, PR
17 Nov 2021Drug	CLASS II	Alprostadil 30mcg/ML Inj 30mcg/ML Injectable recalled by Vita Pharmacy	Vita Pharmacy	Sterility	DC, PR
17 Nov 2021Drug	CLASS II	Alprostadil 45mcg/ML 45mcg/ML Injectable recalled by Vita Pharmacy	Vita Pharmacy	Sterility	DC, PR
17 Nov 2021Drug	CLASS II	Alprostadil 22.5mcg/ML 22.5mcg/ML Injectable recalled by Vita Pharmacy	Vita Pharmacy	Sterility	DC, PR
17 Nov 2021Drug	CLASS II	Alprostadil 22mcg/ML 22mcg/ML Injectable recalled by Vita Pharmacy	Vita Pharmacy	Sterility	DC, PR
17 Nov 2021Drug	CLASS II	Alprostadil 40mcg/ML Inj 40mcg/ML Injectable recalled by Vita Pharmacy	Vita Pharmacy	Sterility	DC, PR
25 Aug 2021Drug	CLASS II	Alprostadil Injection USP, 500 mg/mL single dose recalled	Teva Pharmaceuticals USA	Sterility	Nationwide
15 Apr 2020Drug	CLASS II	Alprostadil 10mcg/Papaverine 30mg/Phentolamine 1mg/ml lnj recalled	Innovative Intrathecal Solutions	Sterility	CA, ME, TX
11 Mar 2020Drug	CLASS II	Alprostadil/Papaverine Hydrochloride/Phentolamine recalled	Fusion IV Pharmaceuticals	Sterility	Nationwide
11 Mar 2020Drug	CLASS II	Alprostadil/Papaverine Hydrochloride/Phentolamine recalled	Fusion IV Pharmaceuticals	Sterility	Nationwide
11 Mar 2020Drug	CLASS II	Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate recalled	Fusion IV Pharmaceuticals	Sterility	Nationwide
11 Mar 2020Drug	CLASS II	Alprostadil/Papaverine Hydrochloride/Phentolamine recalled	Fusion IV Pharmaceuticals	Sterility	Nationwide
11 Mar 2020Drug	CLASS II	Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate recalled	Fusion IV Pharmaceuticals	Sterility	Nationwide
22 Jan 2020Drug	CLASS II	Alprostadil 40 mcg/mL vial) Inj recalled by Assurance Infusion	Assurance Infusion	Sterility	Nationwide
7 Aug 2019Drug	CLASS II	Alprostadil 100 mcg/mL Injectable vial recalled by Wise Pharmacy	Wise Pharmacy	Other	CO, TX, WY
31 Oct 2018Drug	CLASS II	Alprostadil 500 mcg/mL Injectable, Vials, Westlab Pharmacy recalled	Westlab Pharmacy	Packaging Defects	Nationwide
16 May 2018Drug	CLASS II	Alprostadil 20 mcg/mL, Sterile injectable, Vitalab Pharmacy, Inc recalled	Vitalab Pharmacy	Sterility	Nationwide
15 Mar 2017Drug	CLASS II	Edex (alprostadil for injection) 10mcg recalled by Endo PharmaceuticalsEdex	Endo Pharmaceuticals	Sterility	Nationwide
11 Jan 2017Drug	CLASS II	Alprostadil 40 mcg/mL Injectable vials recalled	Wells Pharmacy Network	Sterility	Nationwide
11 Jan 2017Drug	CLASS II	Alprostadil 20 mcg/mL Injectable, a) and b) vials recalled	Wells Pharmacy Network	Sterility	Nationwide
4 Nov 2015Drug	CLASS II	Alprostadil/Procaine, Injectable Solution, 20 Mcg/0.1%/ML vial recalled	JD & SN Inc	Sterility	Nationwide
4 Nov 2015Drug	CLASS II	Alprostadil, Injectable Solution, 40 MCG/ML vials recalled	JD & SN Inc	Sterility	Nationwide
4 Nov 2015Drug	CLASS II	Alprostadil/Procaine, Injectable Solution, 40 Mcg/0.1%/ML and vials recalled	JD & SN Inc	Sterility	Nationwide
23 Sep 2015Drug	CLASS II	Alprostadil 40 mcg/ml Injection, Sterile, Keep Frozen recalled	The Compounding Pharmacy of America	Sterility	Nationwide
23 Sep 2015Drug	CLASS II	Alprostadil 50 mcg/ml Injection, Sterile, Keep Frozen recalled	The Compounding Pharmacy of America	Sterility	Nationwide
23 Sep 2015Drug	CLASS II	Alprostadil 100 mcg/ml Injection, Sterile, Keep Frozen recalled	The Compounding Pharmacy of America	Sterility	Nationwide
23 Sep 2015Drug	CLASS II	Alprostadil 10 mcg/ml Injection, Sterile, Keep Frozen recalled	The Compounding Pharmacy of America	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.