Why it was recalled
Failed Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D.
Product description
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 numbers, UPCs & expiration codes
Lot #: AD81290, AD81291, AD81292 and AD81293, Exp. Date 1/31/2027
Where it was sold
Nationwide within the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0256-2026
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- Dec 30, 2025
- FDA report date
- Jan 21, 2026
- Quantity
- 24,624 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
Original FDA data
Every field from FDA enforcement report D-0256-2026, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 98241
- Address
- 2 Independence Way
- Code information
- Lot #: AD81290, AD81291, AD81292 and AD81293, Exp. Date 1/31/2027
- Postal code
- 08540-6620
- Report date
- Jan 21, 2026
- Product type
- Drugs
- Recall number
- D-0256-2026
- Classification
- Class III
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Product quantity
- 24,624 bottles
- Reason for recall
- Failed Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide within the USA
- Recall initiation date
- Dec 30, 2025
- Initial firm notification
- Letter
- Center classification date
- Jan 13, 2026