Taro Pharmaceutical Industries, a wholly owned subsidiary of Sun Pharmaceutical Industries Ltd., has initiated a major recall of over 17,000 packs of its antifungal shampoo sold in the United States.
The recall follows the identification of quality control issues linked to manufacturing practices. These issues were flagged by the United States Food and Drug Administration (USFDA).
Ciclopirox 1% Shampoo is a prescription antifungal drug widely used to treat seborrheic dermatitis, a scalp condition characterized by itching, dryness, scaling, and inflammation.
17,664 bottles were affected by this recall, which was carried out on December 9, 2025. According to the most recent Enforcement Report by the USFDA, the shampoo failed tests for impurities and degradation, indicating that the shampoo lots did not meet the USFDA’s stringent quality and stability requirements.
These factors are very important for ensuring that an active drug maintains its desired chemical entity. This recall has been labeled a Class II national recall under FDA guidelines, which means that while using the product poses a risk of reversible health effects, there is a relatively low risk of serious side effects.
This type of recall would most likely be voluntary for patients’ safety while the problem is investigated and resolved.
In 2018, Sun Pharma completed the acquisition and merger with Taro Pharmaceutical Industries for approximately USD 347.73 million. The acquisition made them completely private. Since 2010, Sun Pharma has been its majority stakeholder.
Ciclopirox shampoo remains a crucial dermatological drug in the American generics industry, with major suppliers being pharmaceutical manufacturers in the Indian market.
Currently, Indian pharmaceutical companies account for approximately 40% of all prescriptions issued in the American market, underscoring the crucial role of quality compliance in patient care worldwide. Patients and healthcare practitioners are advised to stop using the affected batches and seek alternative treatment options from healthcare professionals.
The move reinforces the scrutiny in the pharmacy industry regarding the regulation of manufacturing processes and the production of high-quality items in relation to the production of safe and effective medication.