Moderate riskFDA DrugClass II

Sun Pharma/Taro ciclopirox shampoo recalled for impurity test failures

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.

From the FDA notice · Read the official notice ↗ · All Sun Pharmaceutical recalls

What to do

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

Is yours affected?

Compare your label or packaging with the recalled product.

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
Sold in
Nationwide
Made for
Adults (0 months and older)

Details

Units affected
17,664 units
Illnesses reported
None reported
Manufactured in
3 Skyline Dr, Hawthorne, NY, United States
Classification
Class II
Recall number
D-0240-2026

In the FDA's words

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 Failed Impurity/Degradation specifications: OOS results obtained at the 18-month timepoint Lot #: AD37059, AD37060, AD37061, AD37062, AD37065, AD37066, AD37067, AD37068, expires: 1/31/2026. Distribution: Nationwide within the United States Affected quantity: 17,664 units
Hazard
Failed Impurity/Degradation specifications: OOS results obtained at the 18-month timepoint

More from Sun Pharmaceutical

See all

Related topics

Industrial chemicalsPotencyDrugsSold nationwideMore from FDA Drug