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
Ciclopirox Shampoo Recall Summary Taro Pharmaceuticals is recalling Ciclopirox Shampoo 1% (120 mL bottles, NDC 51672-1351-08) distributed nationwide because the product failed quality tests for impurities and degradation at the 18-month mark. This is a Class I recall, meaning there is a serious potential health risk. The affected shampoo was distributed across all U.S. states and the District of Columbia.
- Recalling firm
- SUN PHARMA /TARO
- 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
- Reason
- Failed Impurity/Degradation specifications: OOS results obtained at the 18-month timepoint
- Classification
- Class I
- Category
- drug recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2025-12-09
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Nationwide within the United States
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/97add311-d518-4145-ae0c-5e2cca2a7933