FDA Confirms Recalls of High Blood Pressure, Heart Drugs Over Carcinogens

In several notices, the FDA confirmed recalls of beta blockers carvedilol and metoprolol due to high levels of carcinogenic substances.

A U.S. Food and Drug Administration sign outside the agency's White Oak campus in Silver Spring, Md., on July 17, 2025. Issam Ahmed/AFP via Getty Images

The Food and Drug Administration posted notices on recalls of tens of thousands of bottles of two different types of blood pressure and heart medications, upgrading them to the second-highest classification.

In several recall notices posted between Aug. 12 and Aug. 14, the FDA confirmed the recalls of 88,032 bottles of carvedilol tablets, a drug primarily used to treat high blood pressure, or hypertension, and heart failure.

The reason for the recall is due to an elevated presence of the nitrosamine N-nitroso carvedilol I, which was deemed to be “above the current” acceptable intake level, the FDA said.

A nitrosamine is a type of organic compound considered carcinogenic, which can potentially cause cancer, officials say. The FDA website has a section about pharmaceutical medications that have nitrosamine impurities, issuing guidance in 2024 on how companies can comply with the agency’s regulations on the substances.

The recall notices impact Carvedilol Tablets, USP, 12.5 milligram (mg), 500 Tablets per carton; Carvedilol Tablets, USP, 25 mg, 500-count bottle; Carvedilol Tablets, USP, 12.5 mg, 500-count bottle; Carvedilol Tablets, USP, 25 mg, 500 Tablets per carton; and Carvedilol Tablets, USP, 3.125 mg, packaged in a 500-count bottle and a 100-count bottle, the FDA said.

The products were manufactured by New Jersey-based Glenmark Pharmaceuticals Ltd. at its plant based in Goa, India.

The agency last week classified the recalls as Class II, which means there is a “situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote,” the agency says on its website.

At the same time, in a separate recall over nitrosamine impurities, more than 20,000 bottles of metoprolol tartrate tablets, in 50- and 100-milligram strengths, were recalled by Nashville-based Westminster Pharmaceuticals LLC, according to two FDA notices.

The reason for the recall is due to the presence of a nitrosamine known as N-nitroso-metoprolol that is “above the established” levels that people can take daily, the notices said. Those metoprolol recalls were upgraded to Class II by the FDA.

The recalled metoprolol tartrate tablets were made in a plant in Bangladesh by Renata PLC, a drugmaker based in the South Asian country, according to the FDA.

Carvedilol is one of the most commonly prescribed high blood pressure or heart medications in the United States, according to a database on prescription drugs by ClinCalc LLC. More than 4.2 million people took the medication in 2023, the lastest year for which data is available.

Meanwhile, metoprolol is among the most commonly used and prescribed drugs in the country, with 59.5 million prescriptions being issued in 2023, according to the database. More than 14 million people were estimated to have taken the drug that year.

According to the Cleveland Clinic, metoprolol is the most commonly prescribed beta-blocker. Metoprolol is sold under several brand names, including Lopressor and Toprol-XL. Metoprolol succinate extended-release is the generic form of Toprol-XL; however, no branded versions of metoprolol were included in the recall.

Like metoprolol, carvedilol is a beta-blocker that’s used to treat high blood pressure and heart failure.

The FDA says on its website that it has been investigating drugs for nitrosamines in some types of medications, noting they’re common in water and foods. But the agency noted that such impurities have been linked to an increase in cancer in individuals who are exposed to elevated levels and over long periods of time.