Skip to content
Recall Observatory FDA recall evidence

Drug 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

D-0256-2026

December 30, 2025

Class III

Product summary

Firm
SUN PHARMACEUTICAL INDUSTRIES INC
Event
Event 98241
Status
Ongoing
Classification
Class III
Quantity
24,624 bottles
Official record key
drug-enforcement:D-0256-2026

Official wording

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

Code information: Lot #: AD81290, AD81291, AD81292 and AD81293, Exp. Date 1/31/2027

Distribution pattern: Nationwide within the USA

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Out of specification