FDAHealthDecember 9, 2025
SUN PHARMA /TARO — 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
⚠️ Failed Impurity/Degradation specifications: OOS results obtained at the 18-month timepoint
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- December 9, 2025
Nationwide within the United States
What's affected?
- Product
- 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
- Brand
- SUN PHARMA /TARO
- Lot code
- AD37059
Additional details
Lot #: AD37059, AD37060, AD37061, AD37062, AD37065, AD37066, AD37067, AD37068, expires: 1/31/2026.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 17,664 units.
Get Health recall alerts
Delivered to your inbox. Free. No account required.