Carvedilol class action lawsuit overview:
- Who: Plaintiff Sharon Carroll filed a class action lawsuit against Glenmark Pharmaceuticals Inc. USA.
- Why: Carroll claims Glenmark’s Carvedilol was contaminated with nitrosamine impurities and not manufactured according to federal quality standards.
- Where: The Carvedilol class action lawsuit was filed in Washington federal court.
A new class action lawsuit alleges Glenmark Pharmaceuticals sold Carvedilol heart medication that was contaminated with nitrosamine impurities and manufactured outside current federal quality standards.
Plaintiff Sharon Carroll claims she purchased Glenmark’s generic Carvedilol, the equivalent of the branded heart drug Coreg, on multiple occasions in Washington, within the same manufacturing lots she alleges were later linked to nitrosamine contamination and recalled.
Nitrosamines are classified as probable human carcinogens by the U.S. Food and Drug Administration (FDA) and other international health agencies, according to the class action lawsuit.
Carroll alleges Glenmark recalled more than 732,000 bottles of Carvedilol in March 2025 after the FDA cited manufacturing deviations, including the presence of nitrosamine impurities, then issued additional recalls in August 2025 for the same type of contamination.
The Carvedilol class action lawsuit claims Glenmark’s own recall notice acknowledged the nitrosamine impurities “may increase the risk of cancer” and instructed pharmacies to immediately quarantine the affected product.
The lawsuit further claims Carroll would not have purchased the medication, or would have paid less for it, had she known it was contaminated and not manufactured to the same safety standard as the FDA-approved brand-name drug. Carroll says the contamination left her Carvedilol adulterated, misbranded and worthless.
Glenmark allegedly delayed Carvedilol recall until after FDA inspection
According to the class action lawsuit, Glenmark had actual or constructive knowledge of nitrosamine risks for years before its 2025 recalls, citing industry and regulatory guidance dating back to a wave of nitrosamine-related blood pressure drug recalls beginning in 2018.
Carroll alleges Glenmark did not recall its Carvedilol sooner because the company feared losing market share to competitors and claims Glenmark waited to act until after the FDA inspected its manufacturing facility in India in February 2025.
Carroll’s lawsuit accuses Glenmark of breaching express and implied warranties, committing fraud and negligence, violating state consumer protection laws and unjustly enriching itself.
The class action lawsuit seeks to represent a nationwide class of consumers who paid for Glenmark’s Carvedilol, along with a Washington subclass of residents who purchased or received the drug within the state for personal or household use.
The plaintiff demands a jury trial and seeks class certification, injunctive relief and an award of compensatory and punitive damages for herself and other class members.
In other pharmaceutical news, Inventia Healthcare recalled more than 11,000 bottles of its blood pressure medication, Chlorthalidone, due to concerns over alleged dissolution issues and efficacy.
Did you purchase Glenmark’s Carvedilol? Let us know in the comments.
Carroll is represented by Kim D. Stephens and Cecily C. Jordan of Tousley Brain Stephens PLLC and Ruben Honik and David J. Stanoch of Honik LLC.
The Carvedilol class action lawsuit is Carroll v. Glenmark Pharmaceuticals Inc. USA, Case No. 2:26-cv-00327, in the U.S. District Court for the Eastern District of Washington.
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