FDA Updates Recall on Blood Pressure Medication Due to Possible Carcinogen

A notice says Nebivolol tablets are under recall because of a ‘nitrosamine drug substance related impurity.’

The U.S. Food and Drug Administration (FDA) in White Oak, Md., on June 5, 2023. Madalina Vasiliu/The Epoch Times

A third blood pressure medication was recalled across the United States in the past several weeks, according to a notice updated on the U.S. Food and Drug Administration’s (FDA) website on Dec. 16.

The notice said that New Jersey-based Aurobindo Pharma USA Inc. is recalling Nebivolol tablets in 2.5 milligram doses in 30-count bottles, which are only available by prescription. Nebivolol, a type of beta blocker, is used to treat high blood pressure.

The reason for the recall is because of the “presence of nitrosamine drug substance related impurity,” adding that discovered N-nitroso nebivolol levels are above the “acceptable intake limit,” it said. N-nitroso nebivolol is a nitrosamine and is considered mutagenic.

It was first initiated by Aurobindo earlier this month. The FDA classified the recall as Class II on Dec. 16, which occurs when there is a low chance of injury or death, and a possibility of “adverse events” that may have irreversible effects. They are issued if the product can cause medically reversible or temporary health problems—or if there is a small chance of serious health consequences.

The lot numbers being recalled are: NB0224001A and NB0224001B. It has an expiration date of April 2027 and a National Drug Code, or NDC, of 59651-137-30, according to the FDA.

Nitrosamines are compounds that can increase the risk of cancer in individuals if exposed to them above levels established by the FDA, or for long periods of time, the agency says on its website.

“A person taking a drug that contains nitrosamines at-or-below the acceptable daily intake limits every day for 70 years is not expected to have an increased risk of cancer,” the FDA adds.

People who are taking medications with possible “nitrosamine impurities should not stop taking their medications” and should instead speak with a health care professional.

Nitrosamines can be found in small levels in the environment and foods, including “meat, vegetables, and dairy products,” the FDA says.

Some scientists have issued warnings about what they described as widespread nitrosamine contamination in pharmaceutical drugs, noting they are classified as class 1 known mutagenic impurities under the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, a worldwide health body.

In 2023, a Journal of Pharmaceutical Analysis-published research paper found that the presence of the compounds “has raised global safety concerns due to their significant genotoxic and mutagenic effects” and that such “impurities, even in trace amounts, are highly toxic and mutagenic, capable of damaging DNA, and subsequently increase the risk of cancer incidence.”

Other Recent Recalls

In the past two months, two other drugs used to treat high blood pressure were recalled across the United States, according to FDA recall notices.

New York-based Evaric Pharmaceuticals Inc. in November recalled about 200,600 bottles of its Lisinopril tablets in 10-milligram doses after a “pharmacist discovered a metal fragment embedded in a lisinopril 10 mg tablet.” The recall impacts Lisinopril tablets in 10-milligram strength in 90-count bottles.

Weeks before that, Maryland-based Lupin Pharmaceuticals recalled another blood pressure medication, Ramipril, in October because the “active pharmaceutical ingredient was sourced from an unapproved vendor,” the FDA said.

The recall impacts Ramipril capsules in 2.5-milligram strength in 90-count, 100-count, and 500-count bottles, the notice said. The drug, an angiotensin-converting enzyme (ACE) inhibitor used to treat high blood pressure, is only available via a prescription.