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 30-gram tubes nationwide because the product's thickness is too high compared to specifications, discovered during stability testing. 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 cause adverse effects but is unlikely to cause serious harm.
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Product
- Fluocinonide, USP, 0.05% Cream, 30g 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 51672-1386-2.
- 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/d8409a97-2cc8-4dfb-b214-5d12697e23a1