FDA Drugs recall ·

Ciclopirox Shampoo, 1%, 120 mL, Rx only, Mfg by: Taro Pharmaceuticals… recall

Recall number
D-0240-2026
Date
(initiated December 9, 2025)
Company / brand
Sun Pharma /Taro
3 Skyline Dr, Hawthorne, NY, United States
Category
Drugs › Class II
Classification
Class II
Status
Ongoing
Units affected
17,664 units
Initiated by
Voluntary: Firm initiated

Read the official FDA notice ↗

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

Why was it recalled?

Failed Impurity/Degradation specifications: OOS results obtained at the 18-month timepoint

What should you do?

FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.

Product codes & lot numbers

Lot #: AD37059, AD37060, AD37061, AD37062, AD37065, AD37066, AD37067, AD37068, expires: 1/31/2026.

Distribution

Nationwide within the United States

What does Class II mean?

Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.

Source: FDA (drugs), recall D-0240-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.