Sun Pharmaceutical Industries Inc: Fluocinonide, Usp, 0.05% Cream
Recall Summary Fluocinonide 0.05% Cream (a prescription steroid medication) in 60-gram tubes is being recalled nationwide because the product's thickness was found to be higher than acceptable during stability testing. The affected product was manufactured by Taro Pharmaceuticals Inc. 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/b2473683-888c-44ce-9a37-af3c7a2057ae