Phentolamine recalls

The FDA has published 7 recalls involving Phentolamine since 2012. The latest was reported on 24 Dec 2025. Most were for sterility. Novocol Pharmaceutical of Canada 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 recalls7since 2012

Last 12 months1reported

Class I00% of total

Ongoing3latest 24 Dec 2025

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 1 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 6 86%Class III 1 14%

Why phentolamine is recalled

Companies

Novocol Pharmaceutical of Canada114%
Pharmacy Plus114%
Pharm D Solutions114%
Septodont114%
Martin Avenue Pharmacy114%
Lowlite Investments114%
Franck's Lab Inc., d.b.a. Franck's Compounding Lab114%

By year

2025114%
2022114%
2018229%
2014114%
2013114%
2012114%

Ongoing phentolamine recalls

3 active

Reported	Class	Recall	Company	Reason	Where
24 Dec 2025Drug	CLASS II	OraVerse, (Phentolamine Mesylate) Injection, 0.4 mg recalledOraverse	Novocol Pharmaceutical of Canada	Packaging Defects	Nationwide
9 Nov 2022Drug	CLASS II	Phentolamine 10MG/ML Injection, 10MG/ML Solution vial recalled	Pharmacy Plus	Sterility	4 states
17 Jul 2013Drug	CLASS II	Phentolamine 20 mg/ml Injection recalled by Lowlite Investments	Lowlite Investments	Sterility	Nationwide

All phentolamine recalls, newest first

7 total

Reported	Class	Recall	Company	Reason	Where
24 Dec 2025Drug	CLASS II	OraVerse, (Phentolamine Mesylate) Injection, 0.4 mg recalledOraverse	Novocol Pharmaceutical of Canada	Packaging Defects	Nationwide
9 Nov 2022Drug	CLASS II	Phentolamine 10MG/ML Injection, 10MG/ML Solution vial recalled	Pharmacy Plus	Sterility	4 states
7 Nov 2018Drug	CLASS II	Phentolamine 1 mg/Papaverine 15 mg/Alprostadil 150 mcg recalled	Pharm D Solutions	Sterility	Nationwide
16 May 2018Drug	CLASS III	OraVerse (Phentolamine Mesylate) Injection, 0.4 mg recalled by SeptodontOraverse	Septodont	Potency & Assay	CO
5 Nov 2014Drug	CLASS II	Phentolamine mesylate 5 mg/35 mg/mannitol trituration recalled	Martin Avenue Pharmacy	Sterility	Nationwide
17 Jul 2013Drug	CLASS II	Phentolamine 20 mg/ml Injection recalled by Lowlite Investments	Lowlite Investments	Sterility	Nationwide
22 Aug 2012Drug	CLASS II	Phentolamine 10mg/ML Injectable recalled by Franck's Lab Inc., d.b.a.	Franck's Lab Inc., d.b.a. Franck's Compounding Lab	Sterility	Nationwide

Should you stop taking Phentolamine?

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.