Sun Pharma’s U.S. subsidiary, Taro Pharmaceutical Industries, has recalled over 17,000 units of its antifungal shampoo due to manufacturing issues, according to the U.S. Food and Drug Administration.
WASHINGTON, DC – Taro Pharmaceutical Industries, the U.S. arm of Sun Pharma, has initiated a recall of more than 17,000 units of its antifungal shampoo, Ciclopirox Shampoo, due to manufacturing concerns, as reported by the U.S. Food and Drug Administration (USFDA).
The Ciclopirox Shampoo is an antifungal medication used to treat seborrheic dermatitis, a condition characterized by dry, flaky, and itchy skin. The USFDA indicated that the recall was prompted by “failed impurity/degradation specifications” identified during manufacturing.
This Class II nationwide recall, affecting a total of 17,664 units, was officially launched by Taro on December 9. The USFDA categorizes a Class II recall as a situation where the use or exposure to the product may lead to temporary or medically reversible health consequences, with minimal likelihood of serious adverse health outcomes.
Taro Pharmaceutical Industries is a private company wholly owned by Sun Pharma. The Israel-based company was acquired by Sun Pharma in a deal valued at approximately $347.73 million last year. Sun Pharma has been the majority shareholder of Taro since 2010, and the company primarily focuses on dermatology, producing a variety of prescription and over-the-counter products.
Sun Pharmaceutical Industries is a leading exporter to the U.S. market, reporting revenues of Rs 14,478 crore in the second quarter of FY26. Despite this, the company’s net profit saw a year-on-year increase of 2.56 percent, reaching Rs 3,118 crore. However, formulation sales in the U.S. experienced a decline of 4.1 percent, totaling $496 million.
For further details on the recall, consumers are advised to consult the USFDA’s latest Enforcement Report.
According to IANS, the recall highlights the ongoing challenges faced by pharmaceutical companies in maintaining product quality and compliance with regulatory standards.