US FDA Reports Recall Of Sun Pharma’s Antifungal Shampoo

WASHINGTON, DC – Sun Pharma’s US arm, Taro Pharmaceutical Industries, has recalled more than 17,000 units of antifungal shampoo over manufacturing issues, the US Food and Drug Administration (USFDA) has said.

The Ciclopirox Shampoo,  an antifungal medication that treats seborrheic dermatitis, a condition that causes dry, flaky, and itchy skin, is being recalled due to “failed impurity/degradation specifications”, the USFDA said in its latest Enforcement Report. 

The Class II nationwide recall of 17,664 units of the Ciclopirox Shampoo was initiated by the company on December 9.

The USFDA defines a Class-II recall as a violative product whose use, or exposure to, may lead to temporary or medically reversible health consequences, or when the likelihood of serious adverse health outcomes is minimal.

Taro is a private company and wholly owned by Sun Pharma. The Israel-based company was acquired by Sun Pharma in a deal valued at $347.73 million last year. Sun Pharma has been the majority shareholder of Taro since 2010. Primarily focused on dermatology, Taro produces a wide range of prescription and over-the-counter products.

 Sun Pharmaceutical Industries is a lead exporter to the US market, with revenue of Rs 14,478 crore in the second quarter of FY26.

While the drug major’s net profit rose 2.56 percent year-on-year to Rs 3,118 crore, formulation sales in the US declined 4.1 percent to $496 million.  (IANS)