WhichRecall
Class IIIReported 2026-01-21

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

Recalled by SUN PHARMACEUTICAL INDUSTRIES INC

Reason for Recall

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

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Recall Number
D-0256-2026
Classification
Class III
Status
Ongoing
Category
drug
Initiated
2025-12-30
Reported
2026-01-21
Distribution
Nationwide within the USA
Code Info
Lot #: AD81290, AD81291, AD81292 and AD81293, Exp. Date 1/31/2027
Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.
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