Prescription medicine
Selenium
Selenium is a prescription medicine. FDA's NDC Directory lists it from 1 generic labeler.
- Generic listed
Check it at the source: the selenium FDA label on DailyMed (effective November 15, 2023); every selenium label on DailyMed.
Highlights of the record
FDA label of November 15, 2023; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageJuvenile Acne With Blackheads*
Forms and strengths
Injection (solution).
On the market
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 2 of which 1 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 0 since 2012 0 Class I among all firms' recalls; 6 more by firms not listed as its makers
- FAERS reports
- 10 through July 30, 2026
What is selenium used for?
From the label: indications and usageJuvenile Acne With Blackheads*
Source: FDA drug label (Selenium metallicum), Boiron, effective November 15, 2023 (SPL set 86d0ffab-530d-1932-e053-2991aa0aa9b6), via openFDA; the full label on DailyMed
Is there a generic for selenium?
No generic selenium is approved (Drugs@FDA, October 8, 2026).
FDA's NDC Directory lists selenium from 1 labeler under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has selenium been recalled?
The FDA's Enforcement Report lists 6 recalls naming selenium since 2012: 0 Class I (the most serious), 6 Class II, 0 Class III; 0 still ongoing. 6 of them are by firms that FDA's NDC Directory does not list as a maker of selenium and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| January 15, 2020 | Class II | Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical not a listed maker | Lack of Assurance of Sterility |
| May 13, 2016 | Class II | Medaus, Inc. not a listed maker | Lack of Assurance of Sterility |
| June 2, 2015 | Class II | The Compounding Pharmacy of America not a listed maker | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility |
| July 26, 2013 | Class II | Beacon Hill Medical Pharmacy, P.C. not a listed maker | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance |
| July 2, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling: Label Mixup :SELENIUM, Tablet, 50 mcg may have potentially been mislabeled as the following drug: guaiFENesin ER, Tablet, 600 mg, NDC 63824000815 … |
| May 21, 2012 | Class II | Franck's Lab Inc., d.b.a. Franck's Compounding Lab not a listed maker | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What do FAERS reports show for selenium?
The FDA Adverse Event Reporting System holds 10 reports that list selenium among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1 are coded as a death and 3 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Selenium side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other