FLUOCINOLONE ACETONIDE
Recalling Firm / Manufacturer: SUN PHARMACEUTICAL INDUSTRIES INC
(Princeton, NJ, United States)
FDA Recall Number: D-0256-2026
Source Authority Disclaimer: This drug recall notice is published by Questo using official enforcement reports issued by the U.S. Food & Drug Administration (FDA). It is provided for informational, academic, and clinical research purposes only. Patients should not discontinue prescribed treatments without consulting their physician or pharmacist.
Product & Identification Information
Brand, active ingredients, NDC codes, and manufacturer details
Brand / Trade Name
FLUOCINOLONE ACETONIDE
Generic Name
FLUOCINOLONE ACETONIDE
Active Substance(s)
Fluocinolone Acetonide
Administration Route
Topical
National Drug Code (NDC)
51672-1365
Total Quantity Recalled
24,624 bottles
Official Reason for Recall
Specific hazard or quality defect cited by the FDA
According to the official FDA enforcement report:
Failed Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D.
Full Product Description
Packaging specifications and labeling details
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
Enforcement & Regulatory Details
FDA classification, report dates, and initiation authority
Health Hazard Classification
Class III
Current Action Status
Ongoing
FDA Enforcement Report Date
January 21, 2026
Firm Initiation Date
December 30, 2025
FDA Classification Date
Jan 13, 2026
Initiation Type
Voluntary: Firm initiated
Affected Lots & Batch Numbers
Product codes, lot numbers, and expiration dates
Lot #: AD81290, AD81291, AD81292 and AD81293, Exp. Date 1/31/2027
Distribution Information
Geographic scope of affected shipments
Nationwide within the USA
Safety Guidance & Actions
Standard FDA protocol for patients and healthcare providers
Advisory Notice
This Class III recall involves technical or packaging non-conformities that are not expected to cause adverse health consequences. Consult your pharmacist if you have questions.
Official Source Provenance
Verified regulatory citation from U.S. FDA OpenFDA
Primary Data Source: U.S. Food & Drug Administration (FDA) OpenFDA API
Recall Number: D-0256-2026
Questo Retrieval Date: July 31, 2026 14:36 1785508608UTCC