Sun Pharma subsidiary recalls anti-depression drugs in US market

Sun Pharma has said to exchanges in India that it expects to release its second quarter results of FY 24 on November 1

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26 Aug, 2025 12:21

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The US subsidiary of Indian drug maker Sun Pharma recalled an anti-depression medicine from the American markets.

The product was recalled by Sun Pharmaceutical Industries Inc, a US-based wholly owned subsidiary of Sun Pharmaceutical Industries. The company recalled 144 bottles of Bupropion Hydrochloride Extended-Release Tablets, according to the US Food and Drug Administration.

The recall was initiated on October 4 voluntarily by the company, according to the daily US FDA Recall Information updates. The medicines were recalled from all over the US.

The US regulator stated that the reason for this recall was 'failed dissolution specifications'. Bupropion hydrochloride extended-release tablets, USP (SR) are indicated for the treatment of major depressive disorder. The product was manufactured at Sun Pharmaceutical Industries Limited Halol-Baroda Highway, Gujarat.

The recall was classified as a Class-III recall by the US FDA. According to the US FDA, a Class-III recall happens in “a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences”.

Sun Pharma has said to exchanges in India that it expects to release its second-quarter results of FY 24 on November 1.  “Generic sales for Sun were adversely impacted because of an import alert at Halol and supply disruptions from Mohali,” brokerage Nuvama had said in its recent report on the Indian pharma sector.

Shares of Sun Pharma traded marginally up at Rs 1,140.25 on the NSE at 10.18am on October 17.

The company has not responded to email and calls on the matter. The copy will be updated once the company responds on the matter.