Class III

Drug Recall: 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

SUN PHARMACEUTICAL INDUSTRIES INC · December 30, 2025

Reason for Recall

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

Distribution

Nationwide within the USA

States Affected

NATIONWIDE

Quantity Affected

24,624 bottles

Source: FDA (openFDA Drug Enforcement)

Recall number: D-0256-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.