SUN PHARMA /TARO: Drug Recall

Recall #D-0240-2026 · 12/09/2025

Class II: Risk

Recall Details

Recall Number
D-0240-2026
Classification
Class II
Product Type
Drug
Recalling Firm
SUN PHARMA /TARO
Status
Ongoing
Date Initiated
12/09/2025
Location
Hawthorne, NY, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
17,664 units

Reason for Recall

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

Distribution Pattern

Nationwide within the United States

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.