Thousands may be affected by defective pills sold by N.J.-based drug maker, lawsuit says
A New Jersey pharmaceutical company is facing a class-action lawsuit after recalling millions of capsules of a widely prescribed heart medication that may have posed serious health risks.
The lawsuit, filed in federal court in Newark, accuses Glenmark Pharmaceuticals Inc., USA—headquartered in Mahwah—of selling defective potassium chloride capsules that failed to dissolve properly in the body.
Glenmark issued a nationwide recall of 114 batches of the capsules on or around June 25, 2024, after the U.S. Food and Drug Administration flagged the product for failing dissolution tests.
The FDA classified the recall as Class I, its most serious category, indicating a risk of serious injury or death.
The drug is commonly used to treat hypokalemia, or low potassium levels.
Martha Brewton, an Alabama resident, is leading the lawsuit on behalf of herself and other patients in her state who purchased the medication.
She says she was notified by her pharmacy that the pills she received were part of the recall.
According to the FDA and Glenmark’s own statements, the capsules could release potassium too quickly, potentially causing dangerously high potassium levels, irregular heartbeats, and cardiac arrest—especially in patients with heart or kidney conditions.
“In practice, Glenmark’s drug was effectively a rapid-release drug more suitable for an execution rather than the ‘extended-release’ drug the company promised patients,” the complaint alleges.
Brewton’s lawsuit also says it seeks to merge with an earlier case which alleges that Glenmark’s defective potassium chloride capsules caused the death of a Maine woman and endangered thousands of patients nationwide.
Brewton claims Glenmark misled doctors, pharmacies, and patients by labeling the capsules as compliant with U.S. Pharmacopeia standards, which are intended to ensure drug quality and safety.
The complaint argues that the pills were essentially worthless and should never have been sold.
It also points to Glenmark’s history of manufacturing issues.
Since 2019, the company has received multiple FDA warning letters and has issued more than 60 recalls for various drugs due to problems ranging from contamination to improper labeling, the complaint said.
Brewton is seeking compensation for herself and other Alabama residents who bought the recalled pills or similar ones that may have been defective but not officially recalled.
The lawsuit accuses Glenmark of fraud, breach of warranty, and violations of Alabama’s consumer protection laws.
Glenmark did not immediately respond to a request for comment.
Brewton is represented by attorneys Roshan D. Shah, Aaron Block, and Max Marks, who declined to comment on the case.
Colleen Murphy may be reached at cmurphy@njadvancemedia.com.
