⚠ RecallRadar📷 ScanGuidesOfficial U.S. recall notices, restated plainly

SUN PHARMACEUTICAL INDUSTRIES INC: Fluocinolone Acetonide Solution Topical Solution USP, 0.01%, 60-mL bottles, Rx only, Dist. by: Taro Pharmaceuticals Inc., Hawthorn, NY 10532

DrugsSource: FDA (drug) · Date: 2026-01-21

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The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.

Company / brand
SUN PHARMACEUTICAL INDUSTRIES INC
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 / hazard
Failed Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D.
Classification
Class III
Status
Ongoing
Distribution / sold at
Nationwide within the USA
Recall initiated
2025-12-30
Code info
Lot #: AD81290, AD81291, AD81292 and AD81293, Exp. Date 1/31/2027
Product quantity
24,624 bottles
Voluntary mandated
Voluntary: Firm initiated
City
Princeton
State
NJ
Country
United States
Event id
98241
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