India Pharma Outlook Team | Friday, 10 July 2026
Dr. Reddy's API issue is now impacting more than just the company's own semaglutide plans.
In the latest development, Torrent Pharma recall has been announced for select batches of Semalix injection after Dr. Reddy's Laboratories informed the company about an API quality issue.
The move comes a day after Dr. Reddy's disclosed that it had delayed semaglutide supplies due to an impurity detected in the active pharmaceutical ingredient (API), raising concerns about supply disruptions in India's fast-growing obesity and diabetes drug market.
The latest drug recall highlights how a manufacturing issue at one company can affect partners across the pharmaceutical industry. Torrent Pharma clarified that the recall is precautionary and that there is no known risk to patients using the affected batches.
Torrent Pharmaceuticals said it has voluntarily recalled select batches of Semalix Injection 2 mg and 4 mg disposable pens manufactured by Dr. Reddy's. The company took the step after receiving a recall notification from Dr. Reddy's.
According to Torrent, the recall is intended to allow a detailed technical evaluation of the affected batches. The company also stated that no patient safety concerns have been identified so far.
The recall applies only to specific batches manufactured by Dr. Reddy's. Other Semalix products, including the oral formulation and semaglutide products sourced from other manufacturers, remain unaffected.
"Patient safety is of paramount importance to us. There is no risk to patients already on this treatment because of this recall. Further, all other SKUs of Semaglutide being sold by Torrent including the oral formulation remain completely unaffected," according to a stock exchange filing by the company.
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A day before Torrent's announcement, Dr. Reddy's said it had temporarily delayed supplies of its semaglutide products after detecting an impurity in the API during production scale-up.
The company said the issue was identified through its internal quality checks, following which production and supplies were paused. Dr. Reddy's expects the supply disruption to continue until at least late October while it investigates the root cause and completes corrective actions.
Since Dr. Reddy's manufactures the affected Semalix injection batches for Torrent, the quality concern has now resulted in the precautionary recall by Torrent as well.
The development reflects the strict quality standards followed by pharmaceutical companies, where even a potential manufacturing concern can trigger product recalls before any confirmed risk to patients is established.
Semaglutide has emerged as one of the fastest-growing therapies for both type 2 diabetes and weight management, with several Indian drugmakers preparing to expand their presence in the segment.
While the latest developments may temporarily affect supplies of certain products, both companies have maintained that the action is preventive and limited to specific batches. Industry observers believe the incident also underlines the importance of quality control as competition in the semaglutide market continues to increase.
For patients currently using Semalix, Torrent has indicated that the recall is linked to technical evaluation and not to any reported adverse events. Healthcare professionals are expected to guide patients if replacement or alternative supplies become necessary.
Torrent Pharmaceuticals is one of India's leading pharmaceutical companies with a strong presence in cardiovascular, diabetes, central nervous system and gastrointestinal therapies. The company operates in more than 50 countries and continues to expand its specialty and chronic care portfolio.
