FDA recalls more than 233,000 bottles of antidepressant over possible cancer-causing chemicals

More than 233,000 bottles of an antidepressant have been recalled by public health authorities because of a chemical that contains the risk of cancer.

The US Food and Drug Administration classified duloxetine capsules, sold by the New Jersey-based company Rising Pharmaceuticals, as a Class II risk on December 5. The risk level is FDA’s second worst level as it may cause “temporary or medically reversible adverse health consequences.”

The bottles contain the “presence” of the nitrosamine drug impurity, N-nitroso-duloxetine, which exceeds the recommended interim limit according to the FDA.

Rising Pharmaceuticals, which the FDA reported issued a voluntary recall on Nov. 19, did not immediately respond to USA TODAY’s request for comment.

New study: Ultra-processed foods can increase fat and weight, regardless of exercise

The FDA states that nitrosamine impurities “may increase the risk of cancer if people are exposed to them above acceptable levels and over long periods of time.” But it clarifies, “a person who takes a drug containing nitrosamines at or below the acceptable daily intake limits every day for 70 years is not expected to have an increased risk of cancer.”

In October, the FDA initially announced a Class II recall for just 7,107 bottles of duloxetine capsules distributed by Towa Pharmaceutical Europe.

Looking for more recalls? Check out USA TODAY’s recall database

How many bottles of duloxetine were recalled?

According to the FDA, 233,003 bottles have been recalled (delayed-release capsules 30 count, 90 count and 1000 count bottles included).

It was classified as Class II, meaning exposure could trigger “temporary or medically reversible adverse health consequences,” according to the FDA.

What is Duloxetine?

Duloxetine, reportedly known by brand names such as Cymbalta, Drizalma and Irenka, is used to treat mental disorders like anxiety and depression, among other conditions, according to the Cleveland Clinic.

The October 10 recall was of 7,107 duloxetine bottles distributed and manufactured by Towa Pharmaceutical Europe.

The November 19 recall is of 233,003 duloxetine bottles distributed and manufactured by Rising Pharmaceuticals. Both recalls are Class II risks.

What should you do if your medication is recalled?

Officials are urging those who may have medications with potential nitrosamines to stop taking them.

“Patients should talk to their healthcare professionals about concerns and other treatment options,” the FDA’s website states.

What are nitrosamines?

Nitrosamines are found in water, salted and grilled meats, dairy products and vegetables, according to the FDA. While nearly everyone is exposed to trace amounts of nitrosamines, studies link the pollutants to increased cancer risk if people are exposed to large amounts over long periods of time.

More than 12 million bottles of blood pressure-lowering drugs such as valsartan and losartan have been removed from the market since 2018 because they contained nitrosamines.

The same family of contaminants previously triggered recalls of the heartburn drug Zantac, the diabetes drug metformin and the smoking cessation medication Chantix.

Cast: Ken Alltucker

This article originally appeared on USA TODAY: Duloxetine recall: FDA expands recall to more than 233,000 bottles