Selenium recalls

The FDA has published 6 recalls involving Selenium since 2012. The latest was reported on 11 Mar 2020. Most were for sterility. Fusion IV Pharmaceuticals 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 recalls6since 2012

Last 12 months0reported

Class I00% of total

Ongoing0latest 11 Mar 2020

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 6 100%Class III 0 0%

Why selenium is recalled

Sterility583%
Labeling Errors117%

Companies

By year

2020117%
2016117%
2015117%
2014117%
2013117%
2012117%

All selenium recalls, newest first

6 total

Reported	Class	Recall	Company	Reason	Where
11 Mar 2020Drug	CLASS II	Selenium Injection, Selenium 200MCG/ML Injectable recalled	Fusion IV Pharmaceuticals	Sterility	Nationwide
20 Jul 2016Drug	CLASS II	Selenium 200MCG/ML (PF) Vials, Medaus Pharmacy recalled	Medaus	Sterility	Nationwide
23 Sep 2015Drug	CLASS II	Selenium 200 mcg/ml Injectable, Multi-Dose Vial, Sterile recalled	The Compounding Pharmacy of America	Sterility	Nationwide
29 Jan 2014Drug	CLASS II	Selenium, Tablet, 50 mcg, Over The Counter recalled by Aidapak Services	Aidapak Services	Labeling Errors	4 states
18 Sep 2013Drug	CLASS II	Selenium 400 Mcg/ML Injectable, all presentations recalled	Beacon Hill Medical Pharmacy, P.C	Sterility	Nationwide
22 Aug 2012Drug	CLASS II	Selenium 200mcg/ML Injectable (3 Different Products) recalled	Franck's Lab Inc., d.b.a. Franck's Compounding Lab	Sterility	Nationwide

Should you stop taking Selenium?

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.