Over-the-counter medicine
Biotin
Biotin is an over-the-counter medicine. No generic is listed in FDA's NDC Directory.
- No generic listed
- Over the counter
Check it at the source: the biotin FDA label on DailyMed (effective May 9, 2022); every biotin label on DailyMed.
Highlights of the record
FDA label of May 9, 2022; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
The label in openFDA carries no indications section.
Forms and strengths
- 1 mg/100ml
Liquid.
On the market
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 0 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)
- 1 since 2013 0 Class I among all firms' recalls; latest July 30, 2025; 7 more by firms not listed as its makers
- FAERS reports
- 31,021 through July 30, 2026
Is there a generic for biotin?
No generic biotin is approved (Drugs@FDA, October 8, 2026).
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has biotin been recalled?
The FDA's Enforcement Report lists 8 recalls naming biotin since 2013: 0 Class I (the most serious), 7 Class II, 1 Class III; 2 still ongoing. 7 of them are by firms that FDA's NDC Directory does not list as a maker of biotin 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 |
|---|---|---|---|
| July 30, 2025 | Class II | GenoGenix LLC | Lack of Assurance of Sterility |
| March 7, 2022 | Class II | TMC Acquisition LLC dba Tailor Made Compounding not a listed maker | Lack of Assurance of Sterility |
| November 17, 2021 | Class II | ASP CARES not a listed maker | Lack of Assurance of Sterility |
| January 15, 2020 | Class II | Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical not a listed maker | Lack of Assurance of Sterility |
| March 22, 2019 | Class III | Auro Pharmacies Inc. DBA Central Drugs not a listed maker | Failed pH Specification: product does not meet pH label claim. |
| March 22, 2018 | Class II | Partell Specialty Pharmacy not a listed maker | Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization. |
| February 9, 2018 | Class II | American Pharmaceutical Ingredients LLC not a listed maker | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system. |
| April 10, 2013 | Class II | FVS Holdings, Inc. dba. Green Valley Drugs not a listed maker | Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the biotin label say about other medicines?
The biotin label names no other medicine on this site. The labels of 1 other medicine name biotin. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
Source: FDA drug label (Biotitum), Hahnemann Laboratories, INC., effective May 9, 2022 (SPL set de9c9f85-221a-18d2-e053-2a95a90a3c69), via openFDA; the full label on DailyMed
What do FAERS reports show for biotin?
The FDA Adverse Event Reporting System holds 31,021 reports that list biotin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 966 are coded as a death and 5,783 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.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Biotin side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other