FDA-Drug2026-04-22Class II
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.
SUN PHARMACEUTICAL INDUSTRIES INC
Hazard
Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
Sold states
Nationwide in the USA.
Affected count
2,640 60g tubes
Manufactured in
2 Independence Way, N/A, Princeton, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0477-2026Original summary
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. Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing. Lot# AD76250, Exp Date: 6/30/2026. Distribution: Nationwide in the USA. Affected quantity: 2,640 60g tubes
Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief