Sun Pharma’s US arm pulls antifungal shampoo off shelves after quality lapse
CHENNAI: Taro Pharmaceutical Industries, one of the US subsidiaries of India's largest drug maker Sun Pharmaceutical Industries Ltd, has recalled more than 17,000 bottles of an antifungal shampoo from the American market after manufacturing-related quality issues were identified, according to regulatory disclosures.
The company has initiated the recall of Ciclopirox 1% Shampoo, a prescription antifungal product commonly used to treat seborrheic dermatitis of the scalp. The recall covers 17,664 bottles that were distributed across the United States.
The action was taken after the product was found to be out of specification with respect to impurity and degradation parameters. Such deviations raise concerns about whether the medicine continues to meet approved quality and stability standards over its shelf life. While the issue does not point to an immediate or severe health risk, it prompted regulatory intervention to prevent potential adverse effects among users.
The US Food and Drug Administration has classified the action as a Class II recall, which indicates that use of or exposure to the product may cause temporary or medically reversible health consequences, although the probability of serious adverse health outcomes is considered low. Products under this classification are typically removed from the market as a precautionary measure.
Ciclopirox shampoo is widely prescribed for managing fungal infections of the scalp that cause itching, scaling and inflammation. Patients using the recalled batches are generally advised to discontinue use and consult healthcare professionals for suitable alternatives.
Taro Pharmaceutical Industries is a key player in the US generic dermatology segment and operates as a wholly owned subsidiary of Sun Pharma. Sun Pharma, India’s largest drugmaker by revenue, has a significant presence in the US market, which remains its most important source of earnings. The company has, however, faced periodic regulatory scrutiny over manufacturing quality at some of its facilities and subsidiaries, reflecting broader compliance challenges faced by global pharmaceutical manufacturers supplying the tightly regulated US market.
Product recalls related to quality lapses are not uncommon in the pharmaceutical industry, particularly for topical formulations that require strict controls on stability and impurities. While such recalls can have short-term reputational and financial implications, companies often view them as corrective steps to align operations with regulatory expectations and safeguard patient safety.