Glenmark Pharma's carvedilol recalled for impurities, new class action claims

Washington resident Sharon Carroll filed a proposed class action lawsuit against Glenmark Pharmaceuticals Inc. USA on Aug. 4, 2026, in the U.S. District Court for the Eastern District of Washington.

The complaint alleges Glenmark sold generic carvedilol containing N-Nitroso-carvedilol I above the Food and Drug Administration's recommended intake limit without disclosing the impurity to consumers. Carvedilol is a beta-blocker used to treat high blood pressure, congestive heart failure and other heart conditions. Glenmark received FDA approval to sell its generic version in 2007.

Glenmark's recalls

Carroll says she purchased Glenmark carvedilol four times from March 2024 through July 2025. Her prescriptions reportedly carried two National Drug Codes, 68462-0164-05 and 68462-0163-05, both later included in Glenmark recalls, the class action claims.

An FDA enforcement report lists 732,960 bottles in several strengths and package sizes. The agency attributed the recall to manufacturing violations and levels of N-Nitroso-carvedilol I above its acceptable intake limit. Glenmark recalled additional lots in August 2025.

The danger of nitrosamines

Nitrosamines are chemical compounds that reportedly increase cancer risk when people experience long-term exposure above acceptable levels. Glenmark's recall notice said the probability of serious adverse health consequences was remote and reported no related adverse events at the time.

The lawsuit claims the impurity formed during manufacturing when carvedilol reacted with nitrites in inactive ingredients. Glenmark attributed the recall to a failure to control nitrite levels in those ingredients, the complaint says. However, this process could have affected every batch or lot, not only the products listed in the recalls, the suit alleges.

The legal claims

The complaint brings nine claims against Glenmark:

  • Warranty claims, alleging breaches of express and implied warranties and the federal Magnuson-Moss Warranty Act
  • Fraud and negligent misrepresentation, claiming Glenmark misrepresented or withheld information about the medication's contents, manufacturing and safety
  • State consumer protection laws, alleging unfair or deceptive practices under laws across the United States
  • Negligence and negligence per se, claiming Glenmark failed to use reasonable care and violated manufacturing requirements incorporated into state law
  • Unjust enrichment, seeking the return of money Glenmark allegedly received from sales of the medication

What the lawsuit means for Glenmark carvedilol buyers

Carroll seeks purchase and replacement costs, restitution and other relief for a proposed nationwide class of people and entities that paid for Glenmark carvedilol intended for personal or household use. She also proposes a Washington subclass for medication purchased or dispensed in the state.

There is no settlement, claims process or payout.