The US Food and Drug Administration (USFDA) has announced a recall of over 17,000 units of antifungal shampoo, Ciclopirox Shampoo, due to manufacturing issues. The recall was initiated by Taro Pharmaceutical Industries, the US arm of Sun Pharma, on December 9. The shampoo is used to treat seborrheic dermatitis, a condition that causes dry, flaky, and itchy skin. The recall was classified as a Class II recall, which means that the product’s use may lead to temporary or medically reversible health consequences, but the likelihood of serious adverse health outcomes is minimal.
The recall was due to “failed impurity/degradation specifications,” according to the USFDA. Taro Pharmaceutical Industries is a private company and a wholly-owned subsidiary of Sun Pharma, which acquired the Israel-based company in a deal valued at $347.73 million last year. Sun Pharma has been the majority shareholder of Taro since 2010. Taro primarily focuses on dermatology and produces a wide range of prescription and over-the-counter products.
The recall is a setback for Sun Pharma, which is a leading exporter to the US market. In the second quarter of FY26, the company reported revenue of Rs 14,478 crore, with a net profit of Rs 3,118 crore, a 2.56% increase year-on-year. However, formulation sales in the US declined 4.1% to $496 million. The recall highlights the importance of quality control and regulatory compliance in the pharmaceutical industry.
The USFDA’s Enforcement Report noted that the recall was nationwide and affected 17,664 units of the Ciclopirox Shampoo. The company has taken prompt action to address the issue, and the recall is expected to minimize any potential harm to consumers. The incident serves as a reminder of the need for pharmaceutical companies to maintain high standards of quality and manufacturing practices to ensure the safety and efficacy of their products.