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
Reported: December 24, 2025 Initiated: December 9, 2025 #D-0240-2026
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
Reason for Recall
Failed Impurity/Degradation specifications: OOS results obtained at the 18-month timepoint
Details
- Recalling Firm
- SUN PHARMA /TARO
- Units Affected
- 17,664 units
- Distribution
- Nationwide within the United States
- Location
- Hawthorne, NY
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by SUN PHARMA /TARO. Units affected: 17,664 units.
Why was this product recalled? ▼
Failed Impurity/Degradation specifications: OOS results obtained at the 18-month timepoint
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 24, 2025. Severity: Moderate. Recall number: D-0240-2026.
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