FDA-Drug2025-12-24Class IICHEMICAL
Taro Ciclopirox Shampoo 1% recalled for failed purity specifications
What this means
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
The agency's original wording
Hazard
Failed Impurity/Degradation specifications: OOS results obtained at the 18-month timepoint
Intended for
Adults
Illnesses reported
None reported
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-0240-2026Want us to check the next one for you?
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