Sun Pharmaceutical Industries Inc: Fluocinonide, Usp, 0.05% Cream

Recall Summary Sun Pharmaceutical is recalling Fluocinonide 0.05% Cream (a prescription steroid cream) in 15-gram tubes distributed nationwide because the product has higher viscosity (thickness) than required. The affected product was manufactured by Taro Pharmaceuticals in Canada and distributed across all U.S. states. This is a Class II recall, meaning the product could potentially cause adverse health effects, though the company discovered the issue during stability testing rather than through consumer reports.

Recalling firm

SUN PHARMACEUTICAL INDUSTRIES INC

Product

Fluocinonide, USP, 0.05% Cream, 15g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1386-1

Reason

Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.

Classification

Class II

Category

drug recall

Country

United States

Agency

U.S. Food and Drug Administration

Recall date

2026-03-25

Status

Ongoing

Areas affected

AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...

Distribution

Nationwide in the USA.

Official recall notice from U.S. Food and Drug Administration

Recall details on Nibble Recalls: https://trynibble.app/recalls/ff8a21b5-8cc0-42e3-ad77-45602860b95a