Fluocinolone Acetonide Solution
FDA Recall NDC 51672-1365
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Fluocinolone Acetonide (NDC 51672-1365). A significant event, classified as Class III, was initiated on Dec 30, 2025 by Sun Pharmaceutical Industries, Inc.. The reported reason for this action was: "Failed Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
December 2025 Class III Recall: Failed Impurities/Degradation Specifications
Recall Number
Class III Ongoing
Failed Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D.
Dec 30, 2025
Jan 21, 2026
24,624 bottles
Recall Profile & Regulatory Data
Event ID
98241
Classification
Class III
Enforcement Status
Ongoing
Recalling Firm
SUN PHARMACEUTICAL INDUSTRIES INC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the USA
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
Batch or Lot Expiration Information
Lot# : AD81290, AD81291, AD81292 and AD81293, Exp. Date 1/31/2027
Affected Packages Involved in this Recall
51672-1365-2Product
51672-1365-4Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
