Sun Pharmaceutical Industries Inc: Fluocinonide, Usp, 0.05% Cream
Fluocinonide Cream Recall Summary Sun Pharmaceutical is recalling Fluocinonide 0.05% Cream (a prescription steroid cream) in 15-gram tubes because the product's thickness is thicker than the allowed specification. The affected product was distributed nationwide across all U.S. states. This is a Class II recall, meaning the product could potentially cause adverse health effects, though serious injuries are not expected.
- 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/4e7f14d4-e328-4268-840d-1720428c36b5