Ciclopirox Shampoo, 1%, 120 mL, Rx only

SUN PHARMA /TARO has recalled Ciclopirox Shampoo, 1%, 120 mL, Rx only, according to data published by the U.S. Food and Drug Administration (FDA). The recall was reported on December 24, 2025 and was initiated on December 9, 2025. It is classified as a Class II recall, which means using this product might cause a temporary or medically reversible health problem. The chance of serious harm is low.

Below is a plain-English summary of what was recalled, why it was recalled, how to tell whether you have the affected product, and what steps you can take. For the complete and most current details, you can view the FDA record linked further down this page.

What was recalled?

This recall covers Ciclopirox Shampoo, 1%, 120 mL, Rx only, with approximately 17,664 units affected. The company behind the recall is SUN PHARMA /TARO, based in Hawthorne, NY. The FDA describes the product as: “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 was Ciclopirox Shampoo, 1%, 120 mL, Rx only recalled?

According to the FDA, the stated reason for the recall is: “Failed Impurity/Degradation specifications: OOS results obtained at the 18-month timepoint.” In plain terms, this recall relates to a chemical impurity.

This recall involves an unwanted chemical detected in the medicine — often a nitrosamine impurity, which regulators limit because long-term exposure above set levels may increase health risks. Regulators recall affected batches as a precaution. Health authorities generally advise talking to a doctor or pharmacist before stopping a prescribed medicine.

What should you do?

If you think you may have bought Ciclopirox Shampoo, 1%, 120 mL, Rx only, compare it against the product description and identifying codes (Lot #: AD37059, AD37060, AD37061, AD37062, AD37065, AD37066, AD37067, AD37068, expires: 1/31/2026.) before using it. This recall is currently listed as ongoing.

The general guidance for a matching product is to stop using it and follow the instructions in the official FDA recall notice, which may include a repair, replacement, refund, or safe disposal. When in doubt, contact SUN PHARMA /TARO or your local health authority.

About this recall

This recall was distributed in NY. RecallRadar summarizes recall information from public FDA data to make it easier to understand. We are an independent service and are not affiliated with the FDA or any government agency, so please always refer to the official source for the authoritative record — and note the “last synced” date shown on this page, since recall details can change over time.