Ciclopirox Shampoo recall (SUN PHARMA /TARO)
DrugClass IIOngoing
Summary: SUN PHARMA /TARO is recalling 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. Reason: Failed Impurity/Degradation specifications: OOS results obtained at the 18-month timepoint.
What is being recalled
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
Failed Impurity/Degradation specifications: OOS results obtained at the 18-month timepoint
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
Nationwide within the United States
How to tell if yours is affected
Lot #: AD37059, AD37060, AD37061, AD37062, AD37065, AD37066, AD37067, AD37068, expires: 1/31/2026.
What to do
Check the product name, lot number and expiration date on your package against the codes above. If they match, do not stop taking a prescription medicine without talking to your doctor or pharmacist first; ask them about a replacement. Return or dispose of the product as your pharmacy advises.
Recall facts
| Recall number | D-0240-2026 |
| Category | Drug |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | December 9, 2025 |
| Reported | December 24, 2025 |
| Company | SUN PHARMA /TARO |
| Company location | Hawthorne, NY, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 17,664 units |
More recalls from SUN PHARMA /TARO · all drug recalls · recalls from December 2025