Ciclopirox Shampoo Recall: SUN PHARMA /TARO 1% Rx
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 |
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.
How to identify the recalled item
| Lot / date codes | Lot #: AD37059, AD37060, AD37061, AD37062, AD37065, AD37066, AD37067, AD37068, expires: 1/31/2026. |
|---|---|
| Lot / date codes | Lot #: AD37059, AD37060, AD37061, AD37062, AD37065, AD37066, AD37067, AD37068, expires: 1/31/2026. |
These are the identifiers FDA published for this recall. Most recall notices list no UPC or model number at all — if the code on your item is not shown here, that does not mean the item is excluded. Check the official notice, or contact the company.
Other SUN PHARMA /TARO recalls
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.