Glenmark’s Carvedilol Blood Pressure Drug Contaminated with Probable Carcinogen, Class Action Lawsuit Alleges

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Glenmark Pharmaceuticals faces a proposed class action lawsuit that alleges the company’s generic Carvedilol beta-blocker was contaminated with probable carcinogenic impurities and thus adulterated, misbranded, unsafe to sell and unfit for its intended purpose of treating high blood pressure and heart-related conditions. 

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The 139-page class action complaint says that although Carvedilol was touted as therapeutically equivalent to the blockbuster brand-name drug Coreg, Glenmark’s generic version lacked the same safety profile, strength, quality and purity as Coreg due to its contamination with the undisclosed nitrosamine N-Nitroso-Carvedilol I, a probable human carcinogen. 

The suit relays that the U.S. Food and Drug Administration (FDA) announced in March 2025 a nationwide recall of more than 732,000 bottles of Glenmark’s Carvedilol, with further recalls announced in August of that year, due to nitrosamine contamination. Glenmark itself attributed the withdrawal of Carvedilol to nitrosamine impurities, and the contamination to “its failure to control nitrite levels in excipients used during the drug manufacturing process,” the lawsuit says. 

The case charges that Glenmark failed to produce Carvedilol in a manner compliant with current Good Manufacturing Practices (cGMP), in violation of state laws, and without any assurance that the generic was “of the appropriate quality and properly labeled.” 

“Because a manufacturing process failure and testing/quality assurance failure lay at the heart of Glenmark’s process for making Carvedilol, the Products were not made in a cGMP-compliant manner, which rendered the products adulterated and misbranded, and therefore unsellable and worthless (or alternatively, certainly worth some amount less), whether or not a given pill contained nitrosamines or not,” the class action suit summarizes, adding that Glenmark has a documented history of cGMP compliance failures at the overseas facilities at which Carvedilol was made and tested. 

The filing accuses Glenmark of having actual or constructive notice of the potential for and danger of nitrosamine contamination and of “willfully disregard[ing]” scientific and industry guidance regarding their detection and avoidance. According to the case, the contamination in Glenmark’s generic Carvedilol products “dates back many years.” 

“The N-Nitroso-Carvedilol I contamination in Glenmark’s Carvedilol was controllable or avoidable,” the case stresses. “That other generic manufacturers of carvedilol continue to sell their product to this day with no troubling nitrosamine contamination underscores the feasibility of avoiding the contamination, had Glenmark exercised appropriate care.”

The class action lawsuit says that consumers and third-party payors paid for Carvedilol illegally placed into the stream of commerce by Glenmark, resulting in economic damages. 

The Glenmark Carvedilol lawsuit looks to cover all individuals and entities in the United States and its territories and possessions who paid any amount of money for Carvedilol (intended for personal or household use) that was manufactured, distributed or sold by Glenmark Pharmaceuticals.

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