Public health authorities have issued a recall for more than 233,000 bottles of an antidepressant due to contamination with a potentially cancer-causing chemical.

The U.S. Food and Drug Administration categorized capsules of duloxetine, produced by Rising Pharmaceuticals in New Jersey, as a Class II risk on December 5. This designation indicates the potential for “temporary or medically reversible adverse health consequences.”

These bottles were found to contain an impurity, N-nitroso-duloxetine, in excess of the acceptable interim limit, as outlined by the FDA.

Rising Pharmaceuticals, which the FDA stated initiated a voluntary recall on November 19, has not yet provided a comment to YSL News regarding this issue.

The FDA has warned that prolonged exposure to nitrosamine impurities could elevate cancer risks. However, they specified that individuals taking medications containing nitrosamines within acceptable daily intake levels over their lifetime are not expected to face a higher cancer risk.

Previously, in October, the FDA had warned about a Class II recall affecting just 7,107 bottles of duloxetine capsules from Towa Pharmaceutical Europe.

How many bottles of duloxetine are affected?

The FDA reported that a total of 233,003 bottles have been recalled, including 30-count, 90-count, and 1000-count delayed-release capsules.

This classification as Class II means that exposure could lead to “temporary or medically reversible adverse health consequences,” according to the FDA.

What is Duloxetine?

Duloxetine, commonly recognized by brands like Cymbalta, Drizalma, and Irenka, is utilized to address mental health issues such as anxiety and depression, as noted by the Cleveland Clinic.

The earlier recall on October 10 involved 7,107 duloxetine bottles from Towa Pharmaceutical Europe.

In contrast, the recall on November 19 involved 233,003 duloxetine bottles from Rising Pharmaceuticals, with both recalls being categorized as Class II risks.

What should you do if your medication is recalled?

Authorities recommend that anyone with these medications containing potential nitrosamines cease usage.

Patients are advised to consult their healthcare providers regarding their concerns and potential alternative treatments, according to the FDA’s website.

What are nitrosamines?

Nitrosamines can be present in various sources such as water, cured meats, grilled foods, dairy, and vegetables, as per FDA guidance. While most individuals encounter small amounts of nitrosamines, research connects these substances to a heightened cancer risk when consumed in significant quantities over extended periods.

Since 2018, over 12 million bottles of blood pressure medications, including valsartan and losartan, have been recalled due to nitrosamine contamination.

Similar types of impurities have led to recalls for other drugs, including the heartburn medication Zantac, the diabetes treatment metformin, and the smoking cessation product Chantix.