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

The U.S. Food and Drug Administration on Dec. 5 classified duloxetine capsules sold by New Jersey-based Rising Pharmaceuticals as a Class II risk. The risk level is the FDA’s second most serious level because it could cause “transient or medically reversible adverse health effects.”

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

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

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The FDA states that nitrosamine impurities “may increase the risk of cancer when people are exposed to them above acceptable levels and for extended periods of time.” However, it clarifies: “A person who takes one daily for 70 years cannot be expected to “Those taking medications that contain nitrosamines at or below acceptable daily intake limits 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.

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How many bottles of duloxetine have been recalled?

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

It has been assigned Class II, meaning exposure could cause “transient or medically reversible adverse health effects,” according to the FDA.

What is Duloxetine?

According to the Cleveland Clinic, duloxetine, which reportedly goes by brands such as Cymbalta, Drizalma and Irenka, is used to treat mental disorders such as anxiety and depression, among other things.

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

The November 19 recall affects 233,003 bottles of duloxetine 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 be taking medications with potential nitrosamine to stop taking them.

“Patients should speak with their healthcare provider about concerns and other treatment options,” the FDA website says.

What are Nitrosamines?

According to the FDA, nitrosamines are found in water, sausage and grilled meat, dairy products and vegetables. While almost everyone is exposed to trace amounts of nitrosamines, studies link the pollutants to an increased risk of cancer when people are exposed to large amounts over a long period 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 has previously triggered recalls of the heartburn drug Zantac, the diabetes drug Metformin and the smoking cessation drug Chantix.

Contributor: Ken Alltucker

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