Biotin recalls

The FDA has published 6 recalls involving Biotin since 2013. The latest was reported on 15 Oct 2025. Most were for sterility. Partell Specialty 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 recalls6since 2013

Last 12 months1reported

Class I00% of total

Ongoing2latest 15 Oct 2025

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 0 0 0May 0 0 0Aug 0 1 0Nov 0 0 0Feb 0 0 0May 0 0 0Aug 0 0

Severity split

Class I 0 0%Class II 5 83%Class III 1 17%

Why biotin is recalled

Sterility583%
Other Reasons117%

Companies

By year

2025117%
2022117%
2021117%
2019117%
2018117%
2013117%

Ongoing biotin recalls

2 active

Reported	Class	Recall	Company	Reason	Where
15 Oct 2025Drug	CLASS II	Biotin for Injection, all strengths and presentations recalled	GenoGenix	Sterility	Nationwide
20 Jul 2022Drug	CLASS II	Biotin 5mg/mL-vial, Refrigerate, Tailor Made Compounding recalled	TMC Acquisition	Sterility	Nationwide

All biotin recalls, newest first

6 total

Reported	Class	Recall	Company	Reason	Where
15 Oct 2025Drug	CLASS II	Biotin for Injection, all strengths and presentations recalled	GenoGenix	Sterility	Nationwide
20 Jul 2022Drug	CLASS II	Biotin 5mg/mL-vial, Refrigerate, Tailor Made Compounding recalled	TMC Acquisition	Sterility	Nationwide
8 Dec 2021Drug	CLASS II	Biotin Solution for Injection, 10 mg/mL Multiple Dose Vial recalled	ASP Cares	Sterility	TX
17 Apr 2019Drug	CLASS III	Biotin 10 mg/mL Injection vial recalled by Auro Pharmacies	Auro Pharmacies	Other	Nationwide
25 Apr 2018Drug	CLASS II	Biotin Suspension 10mg/mL amber vial recalled	Partell Specialty Pharmacy	Sterility	NV
22 May 2013Drug	CLASS II	Biotin Injection, all strengths recalled by FVS Holdings	FVS Holdings	Sterility	Nationwide

Should you stop taking Biotin?

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.