Drugplain

Biotin 5 mg/100mL

Biotin · LIQUID · Shenzhen yuehaotong Technology Co.,Ltd

10 Recalls on Record
Plain English

Biotin is a liquid containing biotin at 5 mg/100mL, taken topical. Manufactured by Shenzhen yuehaotong Technology Co.,Ltd.

Key Facts

Brand Name
Biotin
Generic Name
Biotin
NDC Code (Product)
87492-002
Manufacturer
Shenzhen yuehaotong Technology Co.,Ltd
Strength
5 mg/100mL
Dosage Form
LIQUID
Route
TOPICAL
Marketing Status
Application #
M032
Drug Class
Arteriolar Vasodilator [EPC]
Marketing Start
03/07/2026

Recall History

10 Recalls on Record
Class II07/30/2025

GenoGenix LLC

Lack of Assurance of Sterility

OngoingVoluntary: Firm initiated
Class II02/09/2018

American Pharmaceutical Ingredients LLC

CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.

TerminatedVoluntary: Firm initiated
Class II01/15/2020

Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical

Lack of Assurance of Sterility

TerminatedVoluntary: Firm initiated
Class I03/25/2016

Reliable Rexall-A Compounding Pharmacy

Labeling: Label Mix-Up: Products labeled Biotin 100 mg found to contain 4-aminopyridine

TerminatedVoluntary: Firm initiated
Class II12/18/2019

MPRX, Inc. dba Medical Park Pharmacy

Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.

TerminatedVoluntary: Firm initiated
Class I06/09/2020

MasterPharm LLC

Super-potent Drug: This recall has been initiated due to the elevated presence of minoxidil and biotin.

TerminatedVoluntary: Firm initiated
Class II07/02/2020

MasterPharm LLC

Lack of Processing Controls (lack of assurance of conformity to specifications).

TerminatedVoluntary: Firm initiated
Class II04/10/2013

FVS Holdings, Inc. dba. Green Valley Drugs

Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.

TerminatedVoluntary: Firm initiated
Class II07/02/2020

MasterPharm LLC

Lack of Processing Controls (lack of assurance of conformity to specifications).

TerminatedVoluntary: Firm initiated
Class II07/02/2020

MasterPharm LLC

Lack of Processing Controls (lack of assurance of conformity to specifications).

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective8,789 reports
adverse drug reaction8,676 reports
fatigue3,517 reports
headache3,459 reports
off label use3,273 reports
alopecia3,035 reports
nausea2,968 reports
application site pruritus2,586 reports
pain2,372 reports
diarrhoea2,289 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

USE To regrow hair the scalp

Dosage & Administration

Directions apply half a capful 2 times a day to the scalp in the hair loss area massage into scalp with fingers, then wash hands. using more or more often will not improve results. continued use is necessary to increase and maintain your hair regrowth or hair loss will begin again

Warnings

WARNINGS For external use only. Extremely Flammable: Avoid Fire, flame, or smoking during and immediately following application.

Frequently Asked Questions

What is Biotin used for?

Biotin contains Biotin. It is a liquid taken topical. Consult your doctor for specific uses.

Is Biotin a controlled substance?

Biotin is not classified as a controlled substance by the DEA.

What is the generic name for Biotin?

The generic name for Biotin is Biotin. There are 3 other brand versions of Biotin.

What is the NDC code for Biotin 5 mg/100mL?

The NDC (National Drug Code) for Biotin 5 mg/100mL is 87492-002, listed by Shenzhen yuehaotong Technology Co.,Ltd.

Product NDC

87492-002

Package NDC

87492-002-01

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)