A common antidepressant medication taken by millions has been voluntarily recalled by the distributor after high levels of a cancer-causing chemical may have been detected.
According to the FDA, nearly 370,000 bottles of Duloxetine delayed-release capsules are being recalled by manufacturer Towa Pharmaceutical and distributor Breckenridge Pharmaceutical Inc. due to levels of N-nitroso-duloxetine that exceeded the FDA’s limit.
While an organic compound also called a nitrosamine, the chemical is toxic if ingested.
The California State Board of Pharmacy stated the toxic chemical “may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time.”
Those exposed to these impurities at or below the acceptable daily intake limit are not expected to have an increased risk of cancer.
Duloxetine is a prescription medication used for the treatment of depression, anxiety, fibromyalgia and certain types of nerve or joint pain.
Also sold under the brand name Cymbalta, it’s a type of selective serotonin and norepinephrine reuptake inhibitor (SSNRI) that works to increase serotonin and norepinephrine, hormones that regulate mood and pain, in the brain.
No adverse effects have been reported in connection with the recalled medication, which included multiple bottles across the 30mg and 60mg dosages.
The affected lot codes are 241074C, 240317, 240318, 240315C, 240373C, 240370C, 240375C, 240413C, 240316, 232311, 240978C, 241052C and 241180C.
The recall was classified as Class II, meaning exposure to the product may cause temporary or medically reversible adverse health consequences, and more serious adverse health consequences are remote.
Often found in tobacco products and several pharmaceuticals, nitrosamines are also present in water and some foods, including cured and grilled meats, dairy products, beer and vegetables.
The toxic chemicals form from food when nitrates used as preservatives react with amines, accelerated by high temperatures or stomach acid.
These compounds can appear in medications through chemical reactions during manufacturing, contaminated ingredients or by breaking down due to heat or moisture over time and interaction with packaging.
This is not the first recall of a medication with elevated nitrosamine levels, however.
A similar recall was issued by Breckenridge Pharmaceuticals in 2024, prompted by the same concern of elevated nitrosamines in more than 7,000 bottles.
The popular anti-smoking drug Chantix was also recalled by Pfizer back in 2021 for a similar issue of containing too much N-nitroso-varenicline, another cancer-causing nitrosamine.
Metformin, a widely-used diabetes medication, has been recalled numerous times, as most recently as 2021, for containing possible carcinogens.
The FDA previously recommended that “patients talk to their health care professional about the best course of action for their health if they have a medication that has been recalled.”
Immediately stopping duloxetine can cause withdrawal side effects with short-term effects appearing in as little as a few hours and lasting for up to 6 weeks.
