Ciclopirox Shampoo Recall: SUN PHARMA /TARO 1% Rx
Announced 2025-12-24 · FDA
FDA recall of SUN PHARMA /TARO Ciclopirox Shampoo, 1%, 120 mL, Rx only. The product is manufactured by Taro Pharmaceuticals Inc. in Ontario, Canada and distributed nationwide in the United States. The recall is due to failed impurity/degradation specifications with out-of-spec results at the 18-month timepoint. Approximately 17,664 units across eight lots (AD37059–AD37068) are affected and expire 01/31/2026.
| Brand | SUN PHARMA /TARO |
|---|---|
| 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 |
| Reason | Failed Impurity/Degradation specifications: OOS results obtained at the 18-month timepoint |
| Severity | moderate |
| Units affected | 17664 |
| Distribution | Nationwide within the United States |
| Agency | FDA |
| Recall / campaign no. | Lot #: AD37059, AD37060, AD37061, AD37062, AD37065, AD37066, AD37067, AD37068, expires: 1/31/2026. |
WHAT YOU SHOULD DO
- Check if your bottle's lot number is AD37059, AD37060, AD37061, AD37062, AD37065, AD37066, AD37067, or AD37068 and note the expiration date.
- Stop using the product if it matches one of the listed lots and set it aside.
- Contact the retailer or Taro Pharmaceuticals USA for instructions on return, refund, or replacement.
- If you have used the product and have health concerns, consult your healthcare provider and report adverse events to the FDA MedWatch program.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.