NEED TO KNOW
Nearly 370,000 bottles of Duloxetine were recalled due to potential contamination with a cancer-causing compound
The recall follows a similar incident in 2024 when more than 7,000 bottles were pulled for potential nitrosamine contamination
PEOPLE has reached out to distributor Breckenridge Pharmaceutical Inc. for comment
Thousands of bottles of a popular antidepressant have been recalled as they may contain high levels of a cancer-causing compound.
Nearly 370,000 bottles of Duloxetine, a prescription medication used to treat depression, anxiety, and nerve damage, have been voluntarily recalled, according to a report from Fox 8. The pills may contain the “presence of N-nitroso-duloxetine impurity above FDA recommended interim limit,” per an alert from the U.S. Food and Drug Administration.
Stock image of bottles of Duloxetine
Credit: Dhiraj Singh/Bloomberg via Getty
N-nitroso-duloxetine is a compound that’s “suspected of causing cancer,” according to the National Library of Medicine, which notes it’s “toxic if swallowed.”
However, the California State Board of Pharmacy says that exposure doesn’t immediately cause cancer, explaining “nitrosamines are common in water and foods, including cured and grilled meats, dairy products, and vegetables. Everyone is exposed to some level of nitrosamines. These impurities may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time.”
The recall is classified as a Class II recall, meaning, “a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.” This is the agency’s second most serious classification of recall.
PEOPLE has reached out to Breckenridge Pharmaceutical, Inc., which initiated the recall, for comment. Per the California State Board of Pharmacy, the distributor was “not aware of reports of adverse events that have been assessed to be related to this recall.”
The recall impacts nearly 370,000 bottles of medication. Impacted lot codes include: 241074C, 240317, 240318, 240315C, 240373C, 240370C, 240375C, 240413C, 240316, 232311, 240978C, 241052C, and 241180C.
Stock image of a woman reaching into her medicine cabinet
Credit: Getty
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As the Mayo Clinic explains, Duloxetine is a type of selective serotonin and norepinephrine reuptake inhibitor (SSNRIs) which works by increasing serotonin and norepinephrine in the brain. Along with depression and anxiety, it’s often prescribed to treat fibromyalgia and nerve pain associated with diabetes.
This is the second recall of Duloxetine tied to the same potentially carcinogenic compound. In October 2024, more than 7,000 bottles were recalled for potential nitrosamine contamination.
Read the original article on People