FDA-Drug2025-12-24Class IICHEMICAL

Taro Ciclopirox Shampoo 1% recalled for failed purity specifications

OTHERNationwide distribution

Stop using Taro Ciclopirox Shampoo 1%

Taro Pharmaceuticals is recalling specific lots of Ciclopirox Shampoo 1% because the product failed quality tests for impurities and degradation at the 18-month mark. The affected lots expire January 31, 2026. No injuries have been reported.

  • Check if you have Ciclopirox Shampoo with lot numbers AD37059, AD37060, AD37061, AD37062, AD37065, AD37066, AD37067, or AD37068
  • Stop using the product if you have an affected lot
  • Return it to your pharmacy or dispose of it safely
  • Contact your doctor if you have questions about treatment alternatives
Hazard

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

Sold states
Nationwide within the United States
Affected count
17,664 units
Manufactured in
3 Skyline Dr, Hawthorne, NY, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0240-2026

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