December 2025 FDA Recall Fluocinolone Acetonide by Sun Pharmaceutical Industries Inc
D-0256-2026 - Failed Impurities/Degradation Specifications
This Class III drug recall was voluntarily initiated by Sun Pharmaceutical Industries Inc on December 30, 2025 for the product Fluocinolone Acetonide. The FDA reported the reason for recall as failed impurities/degradation specifications. The product was distributed Nationwide and the recall is currently ongoing.
Recall Number: D-0256-2026
Failed Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D.
12-30-2025
01-21-2026
24,624 bottles
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
SUN PHARMACEUTICAL INDUSTRIES INC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide within the USA
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# : AD81290, AD81291, AD81292 and AD81293, Exp. Date 1/31/2027
