Why it was recalled
Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
Product description
Fluocinonide, USP, 0.05% Cream, 30g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1386-2.
Lot numbers, UPCs & expiration codes
Lot# AD76251, Exp Date: 6/30/2026.
Where it was sold
Nationwide in 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-0476-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Mar 25, 2026
- FDA report date
- Apr 22, 2026
- Quantity
- 41,712 30g tubes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
Original FDA data
Every field from FDA enforcement report D-0476-2026, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 98677
- Address
- 2 Independence Way
- Code information
- Lot# AD76251, Exp Date: 6/30/2026.
- Postal code
- 08540-6620
- Report date
- Apr 22, 2026
- Product type
- Drugs
- Recall number
- D-0476-2026
- Classification
- Class II
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Product quantity
- 41,712 30g tubes
- Reason for recall
- Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Fluocinonide, USP, 0.05% Cream, 30g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1386-2.
- Distribution pattern
- Nationwide in the USA.
- Recall initiation date
- Mar 25, 2026
- Initial firm notification
- Letter
- Center classification date
- Apr 13, 2026