FDAFDA · Food and drugs·Recall number D-0256-2026
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
Published January 21, 2026 · Recall initiated: December 30, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- FLUOCINOLONE ACETONIDE
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES INC
- Distributor
- Nationwide within the USA
- Lot
- Lot #: AD81290, AD81291, AD81292 and AD81293, Exp. Date 1/31/2027
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.