Torrent Pharmaceuticals has announced a recall of select batches of Semalix Injection 2 mg and 4 mg following an Active Pharmaceutical Ingredient (API)-related quality issue identified in products manufactured by Dr. Reddy's Laboratories.

The recall follows the discovery that certain batches of semaglutide failed to meet quality specifications due to an issue associated with the API. Torrent clarified that the action is limited to the affected batches and does not extend to its broader semaglutide portfolio.

According to the company, all other Semalix products, including Semalix tablets, the 8 mg Semalix injection manufactured by MSN Laboratories, and the Sembolic reusable injection manufactured by Zydus Lifesciences, remain unaffected and continue to be available in the market.

Torrent stated that it is investigating the root cause of the quality deviation in collaboration with the manufacturer and is implementing appropriate corrective measures to ensure consistent product quality.

The company also emphasized that patient safety has not been compromised. In a statement, Torrent said there is no risk to patients currently receiving treatment with the affected product and reiterated that all other semaglutide formulations marketed by the company remain unaffected.

The company indicated that the financial impact of the recall is expected to be minimal, as its semaglutide business is currently limited to the Indian market with estimated monthly sales of INR 15–16 crore. Torrent sources semaglutide products from three different manufacturing partners for various strengths and delivery formats, while also producing two strengths through its own manufacturing operations, helping to mitigate the impact of the recall.