D-0256-2026 Class III Ongoing

Recalled by SUN PHARMACEUTICAL INDUSTRIES INC — Princeton, NJ

Recall Details

Product Type
Drugs
Report Date
January 21, 2026
Initiation Date
December 30, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
24,624 bottles

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.

Distribution Pattern

Nationwide within the USA

Code Information

Lot #: AD81290, AD81291, AD81292 and AD81293, Exp. Date 1/31/2027