Why it was recalled
Failed Impurity/Degradation specifications: OOS results obtained at the 18-month timepoint
Product description
Ciclopirox Shampoo, 1%, 120 mL, Rx only, Mfg by: Taro Pharmaceuticals Inc., Ontario, Canada; Dist. by: Taro Pharmaceuticals USA, Inc., NY 10532. NDC 51672-1351-08
Lot numbers, UPCs & expiration codes
Lot #: AD37059, AD37060, AD37061, AD37062, AD37065, AD37066, AD37067, AD37068, expires: 1/31/2026.
Where it was sold
Nationwide within the United States
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-0240-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Dec 9, 2025
- FDA report date
- Dec 24, 2025
- Quantity
- 17,664 units
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- SUN PHARMA /TARO
Original FDA data
Every field from FDA enforcement report D-0240-2026, exactly as published.
Show all FDA fields
- City
- Hawthorne
- State
- NY
- Status
- Ongoing
- Country
- United States
- Event ID
- 98104
- Address
- 3 Skyline Dr
- Code information
- Lot #: AD37059, AD37060, AD37061, AD37062, AD37065, AD37066, AD37067, AD37068, expires: 1/31/2026.
- Postal code
- 10532-2174
- Report date
- Dec 24, 2025
- Product type
- Drugs
- Recall number
- D-0240-2026
- Classification
- Class II
- Recalling firm
- SUN PHARMA /TARO
- Product quantity
- 17,664 units
- Reason for recall
- Failed Impurity/Degradation specifications: OOS results obtained at the 18-month timepoint
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Ciclopirox Shampoo, 1%, 120 mL, Rx only, Mfg by: Taro Pharmaceuticals Inc., Ontario, Canada; Dist. by: Taro Pharmaceuticals USA, Inc., NY 10532. NDC 51672-1351-08
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Dec 9, 2025
- Initial firm notification
- Letter
- Center classification date
- Dec 17, 2025