Fluocinolone Acetonide Solution Topical Solution USP, 0.01%, 60-mL bottles, Rx only, Dist. by: Ta...
FDA Recall #D-0256-2026 — Class III — December 30, 2025
Product Description
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.
Recalling Firm
SUN PHARMACEUTICAL INDUSTRIES INC — Princeton, NJ
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
24,624 bottles
Distribution
Nationwide within the USA
Code Information
Lot #: AD81290, AD81291, AD81292 and AD81293, Exp. Date 1/31/2027
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated