Medications & Supplements/Topical Products

Mayne Pharma Inc: Fabior (tazarotene) Foam Recalled for High Potency Levels

Agency Publication Date: March 30, 2018

Summary

Mayne Pharma Inc. is voluntarily recalling approximately 3,312 cans of Fabior (tazarotene) Foam, 0.1%, which is a prescription medication used to treat acne. The recall was initiated because stability testing at the nine-month mark showed the drug was 'superpotent,' meaning it contains a higher concentration of the active ingredient than specified. Consumers should contact their healthcare provider or pharmacist regarding the use of this product and return any remaining medication to their pharmacy.

Risk

A superpotent topical drug can increase the risk of localized skin reactions, such as severe redness, peeling, or irritation, because the concentration of the active ingredient tazarotene is higher than the approved therapeutic level.

What You Should Do

Locate your Fabior (tazarotene) Foam, 0.1%, 100-gram can and check the packaging for the identifying NDC number 51862-295-10.
Check the bottom of the can or the side of the carton for Lot number MBEB with an expiration date of 01/31/2019 to see if your medication is affected.
If your medication matches the affected lot, contact your healthcare provider or pharmacist immediately to discuss your treatment and potential side effects.
Return any unused portions of the affected medication to the pharmacy where you purchased it to receive a refund.
Contact Mayne Pharma Inc. at their Greenville, NC office for further instructions regarding this recall.
For additional questions or to report a side effect, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Fabior (tazarotene) Foam, 0.1% (100 grams can)

Model:

NDC 51862-295-10

Lot Numbers:

MBEB (Exp. 01/31/2019)

Date Ranges: Expiration date 01/31/2019

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 79604

Status: Resolved

Manufacturer: Mayne Pharma Inc

Sold By: pharmacies

Manufactured In: United States

Units Affected: 3312 cans

Distributed To: Nationwide

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Locate your Fabior (tazarotene) Foam, 0.1%, 100-gram can and check the packaging for the identifying NDC number 51862-295-10.

Check the bottom of the can or the side of the carton for Lot number MBEB with an expiration date of 01/31/2019 to see if your medication is affected.

If your medication matches the affected lot, contact your healthcare provider or pharmacist immediately to discuss your treatment and potential side effects.

Return any unused portions of the affected medication to the pharmacy where you purchased it to receive a refund.

Contact Mayne Pharma Inc. at their Greenville, NC office for further instructions regarding this recall.

For additional questions or to report a side effect, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.