FDA Drugs recall ·
Fluocinolone Acetonide Solution Topical Solution USP, 0.01%… recall
- Recall number
- D-0256-2026
- Date
- (initiated December 30, 2025)
- Company / brand
- Sun Pharmaceutical Industries Inc
2 Independence Way, Princeton, NJ, United States - Category
- Drugs › Class III
- Classification
- Class III
- Status
- Ongoing
- Units affected
- 24,624 bottles
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
Failed Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot #: AD81290, AD81291, AD81292 and AD81293, Exp. Date 1/31/2027
Distribution
Nationwide within the USA
What does Class III mean?
Class III means use of or exposure to the product is not likely to cause adverse health consequences (for example, a labeling violation).
Source: FDA (drugs), recall D-0256-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.