FDAHealthDecember 30, 2025
SUN PHARMACEUTICAL INDUSTRIES INC — 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
⚠️ Failed Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- December 30, 2025
Nationwide within the USA
What's affected?
- 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
- Lot code
- AD81290
Additional details
Lot #: AD81290, AD81291, AD81292 and AD81293, Exp. Date 1/31/2027
What should I do?
Recommended action
Class III recall. Voluntary: Firm initiated Quantity affected: 24,624 bottles.
Get Health recall alerts
Delivered to your inbox. Free. No account required.