Sun Pharmaceutical Industries Inc: Fluocinonide, Usp, 0.05% Cream
Recall Summary Sun Pharmaceutical is recalling Fluocinonide 0.05% Cream (a prescription steroid cream) in 60-gram tubes distributed nationwide because the product's thickness is thicker than the specification allows, which was discovered during stability testing. This is a Class II recall, meaning the product could cause adverse health effects. The affected product was manufactured by Taro Pharmaceuticals in Canada and distributed across all U.S. states and Washington, D.C.
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Product
- Fluocinonide, USP, 0.05% Cream, 60g 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 51672-1386-3.
- 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/0272b71d-bbd1-452e-88f1-11558fb4ee8c