Fluocinolone Acetonide Solution Topical Solution Usp, 0.01%, 60-ml Bottles, Rx Only, Dist. By: Taro Pharmaceuticals Inc., Hawthorn, Ny 10532. Ndc 51672-1365-4

Recall Summary Fluocinolone Acetonide Solution 0.01% in 60-mL bottles distributed by Taro Pharmaceuticals (NDC 51672-1365-4) is being recalled nationwide because testing found higher-than-acceptable levels of a known impurity. This is a prescription topical steroid solution that was distributed across all U.S. states.

Recalling firm

SUN PHARMACEUTICAL INDUSTRIES INC

Product

Fluocinolone Acetonide Solution Topical Solution USP, 0.01%, 60-mL bottles, Rx only, Dist. by: Taro Pharmaceuticals Inc., Hawthorn, NY 10532. NDC 51672-1365-4

Reason

Failed Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D.

Classification

Class I

Category

drug recall

Country

United States

Agency

U.S. Food and Drug Administration

Recall date

2025-12-30

Status

Ongoing

Areas affected

AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...

Distribution

Nationwide within the USA

Official recall notice from U.S. Food and Drug Administration

Recall details on Nibble Recalls: https://trynibble.app/recalls/a34d4570-4e07-4e2f-b5fb-1c4b8725a089