A commonly used prescription antidepressant medication is being recalled because it may contain a carcinogenic substance, the Food and Drug Administration announced.
New Jersey-based Breckenridge Pharmaceutical, Inc., is recalling 14,729 bottles of duloxetine delayed-release capsules in 30-milligram doses, contained in 1,000-count bottles, according to a notice that was published on the FDA’s recall database this week. The medication has an expiration date of April 2027 with a lot number of 241180C.
The medication was manufactured by Towa Pharmaceutical Europe in Barcelona, Spain, and distributed by Breckenridge Pharmaceutical, the notice said. Neither company issued a press release for the recall.
Duloxetine, which is commonly sold under the Cymbalta brand, is used to treat depression, generalized anxiety disorder, fibromyalgia, and chronic musculoskeletal pain, according to the Mayo Clinic. Drug database website ClinCalc listed it as the 31st most commonly prescribed drug in the United States, with more than 18 million estimated prescriptions for the medication for about 4.2 million patients in 2023.
The FDA on June 8 labeled the recall as Class II, which the agency says is 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.”
The recall notice said the action was initiated due to “CGMP deviations” and the “presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.” Nitrosamines are potentially cancer-causing organic chemical compounds whose levels in medication are regulated by the FDA.
While people are commonly exposed to trace amounts of nitrosamines in their daily life, health officials discourage excessive long-term exposure.
“These impurities may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time,” said an alert from the California State Board of Pharmacy about the recall. The company said that it was not aware of any adverse events associated with the recalled drug.
Meanwhile, the FDA says on its website that “a person taking a drug that contains nitrosamines at-or-below the acceptable daily intake limits every day for 70 years is not expected to have an increased risk of cancer.”
Over the past several years, several medications have been recalled due to elevated levels of nitrosamines, compounds that are commonly found in prescription drugs. In March, around 175,000 bottles of prazosin hydrochloride capsules, manufactured by Appco Pharma LLC, were recalled due to the presence of a nitrosamine impurity, a separate notice said.
The duloxetine recall is nationwide and ongoing, according to the notice. Breckenridge Pharmaceutical initiated the recall on June 4.