SUN PHARMACEUTICAL INDUSTRIES INC recalls Fluocinolone Acetonide Solution Topical Solution USP
- Recalling company
- SUN PHARMACEUTICAL INDUSTRIES INC
- 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
- Reason
- Failed Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D.
- Classification
- Class III – not likely to cause adverse health consequences
- Recall date
- Dec 30, 2025
- Reported
- Jan 21, 2026
- Distribution
- Nationwide within the USA
- Status
- Ongoing
- Quantity
- 24,624 bottles
- Lot / codes
- Lot #: AD81290, AD81291, AD81292 and AD81293, Exp. Date 1/31/2027
- Company location
- Princeton, NJ
- Recall type
- Voluntary: Firm initiated
- Recall number
- D-0256-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number D-0256-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.