Data Composite

Recall D-0256-2026

US Class III Ongoing · initiated 2025-12-30

Recalling firm

SUN PHARMACEUTICAL INDUSTRIES INC, NJ

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 for recall

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

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