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In a troubling development for patients across the country, the U.S. Food and Drug Administration (FDA) has upgraded a nationwide recall of over 732,000 bottles of carvedilol tablets—an extensively prescribed heart and blood pressure medication—due to elevated levels of N-Nitroso Carvedilol, a known carcinogenic contaminant. The affected products were manufactured by Glenmark Pharmaceuticals Inc., a company based in New Jersey.
This recall is classified as a Class II recall, meaning there is a possibility of reversible or medically treatable adverse health effects, and while the immediate risk may seem low, the long-term cancer risks are deeply concerning. Nitrosamines, including N-Nitroso Carvedilol, are not new to public health discussions. These compounds are mutagenic and genotoxic—capable of altering DNA and raising the risk of cancer with chronic exposure, even at trace levels.
If you or a loved one took carvedilol and have since been diagnosed with cancer, you may have legal grounds to pursue compensation.
Carvedilol is a beta blocker widely prescribed to treat high blood pressure, heart failure, and to improve survival after heart attacks. In 2022 alone, more than 17 million patients in the U.S. were prescribed this drug, making it the 34th most prescribed medication in the nation.
The contaminated carvedilol tablets were distributed nationwide in multiple dosage forms and were later found to contain N-Nitroso Carvedilol I at levels exceeding the FDA’s acceptable daily intake limit. This contaminant is part of the nitrosamine family, a group of chemicals that have been linked to cancer in both animal and human studies.
The patients most likely affected include:
N-Nitroso Carvedilol belongs to the broader class of nitrosamine impurities, which have been the subject of multiple FDA recalls over the past several years. According to the Journal of Pharmaceutical Analysis, these compounds have high genotoxicity, which means they are capable of damaging DNA, potentially leading to cancer over time.
These chemicals are especially dangerous when ingested consistently, as would be the case for someone taking a daily carvedilol tablet for heart-related conditions. The FDA has acknowledged that nitrosamines above certain thresholds are not safe for human consumption, even if there are no immediate symptoms.
The fact that Glenmark Pharmaceuticals reported no injuries does not eliminate the risk. Many cancers linked to nitrosamine exposure—such as liver, bladder, stomach, pancreatic, and esophageal cancers—may not appear for years after exposure.
While the FDA upgraded this recall in June 2025, the problem dates back to February 2025, when the company initially began withdrawing the affected lots. In the months that followed, updated testing revealed that the contamination exceeded FDA limits, prompting the reclassification.
In response to increasing discoveries of nitrosamines in common drugs, the FDA also issued updated guidance in late 2024 instructing manufacturers to reduce or eliminate these contaminants. Still, the Glenmark recall indicates serious lapses in quality control and pharmaceutical safety compliance.
The pharmaceutical industry has a legal and moral obligation to ensure that its products are free of dangerous impurities. Failing to detect and remove known carcinogens from drugs used by millions of Americans is not only unacceptable—it’s potentially actionable in court.
You may be eligible to file a lawsuit if:
Even if you are unsure of the manufacturer, an attorney can help track down pharmacy records to confirm whether you were exposed to the recalled product.
Victims who qualify for a carvedilol cancer lawsuit may be entitled to compensation for:
Each case will be evaluated based on medical evidence, usage history, and the specific cancer diagnosis.
Parker Waichman LLP is actively investigating claims involving patients harmed by contaminated carvedilol tablets. Our legal team has extensive experience pursuing dangerous drug cases and holding pharmaceutical companies accountable.
We are currently representing clients across the country who were unknowingly exposed to cancer-causing chemicals in their medications. Our attorneys work with medical experts, review product documentation, and build strong legal cases designed to recover the maximum possible compensation for our clients.
There are strict deadlines for filing these types of claims. If you delay, you could lose your right to sue. Our attorneys will guide you step-by-step, with no upfront fees—we only get paid if we win your case.
If you or a loved one took carvedilol and were later diagnosed with cancer, you may have a claim. Parker Waichman LLP is currently investigating legal actions against Glenmark Pharmaceuticals for manufacturing contaminated carvedilol tablets. Our national product injury law firm is standing by to evaluate your case and help you fight for justice.
Don’t wait. Call 1-800-YOUR-LAWYER (1-800-968-7529) today for a free consultation. There are no legal fees unless we recover compensation for you.
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