Medications & Supplements/Prescription Drugs

Taro Pharmaceuticals U.S.A., Inc.: Fluocinonide Gel Recalled for Potential Dapsone Cross-Contamination

Agency Publication Date: December 29, 2017

Summary

Taro Pharmaceuticals U.S.A., Inc. is recalling 16,944 tubes of Fluocinonide Gel USP (0.05%), a prescription topical medication used for skin conditions. This recall was initiated because traces of Dapsone, a different medication, were found in the finished product due to cross-contamination during manufacturing. Consumers who have this specific 15 gram tube should contact their healthcare provider or pharmacist for guidance and to arrange for a refund.

Risk

The presence of trace amounts of Dapsone in a product not intended to contain it poses a risk of unexpected side effects or allergic reactions for users sensitive to Dapsone.

What You Should Do

Check your medication packaging for Fluocinonide Gel USP, 0.05% in a 15 g tube with NDC number 51672-1279-1.
Locate the lot number and expiration date on the tube or box to see if it matches Lot #: A771026850 with an expiration date of 6/18.
If your product matches this lot number, contact your healthcare provider or pharmacist immediately to discuss your treatment and how to obtain a replacement.
Return any unused portion of the affected medication to your pharmacy for a refund.
Contact Taro Pharmaceuticals U.S.A., Inc. at their Hawthorne, NY location for further instructions regarding this recall.
For additional information, 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

Pharmacy refund and healthcare consultation

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

Affected Products

Product: Fluocinonide Gel USP, 0.05% (15 g tube)

Model:

NDC 51672-1279-1

Recall #: D-0146-2018

Lot Numbers:

A771026850 (Exp 6/18)

Date Ranges: Expiration Date: June 2018

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 78157

Status: Resolved

Manufacturer: Taro Pharmaceuticals U.S.A., Inc.

Sold By: Pharmacies

Manufactured In: Canada, United States

Units Affected: 16,944 tubes

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

Check your medication packaging for Fluocinonide Gel USP, 0.05% in a 15 g tube with NDC number 51672-1279-1.

Locate the lot number and expiration date on the tube or box to see if it matches Lot #: A771026850 with an expiration date of 6/18.

If your product matches this lot number, contact your healthcare provider or pharmacist immediately to discuss your treatment and how to obtain a replacement.

Return any unused portion of the affected medication to your pharmacy for a refund.

Contact Taro Pharmaceuticals U.S.A., Inc. at their Hawthorne, NY location for further instructions regarding this recall.

For additional information, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.