Hundreds of thousands of bottles of a widely used antidepressant have been recalled due to concerns over possible contamination with a chemical considered a probable human carcinogen. The U.S. Food and Drug Administration (FDA) initiated the recall for more than 370,000 bottles of duloxetine delayed-release capsules, distributed by Breckenridge Pharmaceuticals.
The recall specifically affects 360,000 bottles of 60 milligram (mg) capsules, sold in quantities of 90 or 1,000 capsules, and 14,000 bottles of 30mg capsules sold in 1,000-count bottles. These prescription medications have expiration dates extending up to May of next year and were distributed nationwide.
The FDA's concern stems from test results indicating that the capsules contained higher than permitted levels of N-nitroso-duloxetine. While no illnesses have been reported to date, the FDA classified this as a Class II recall, signifying that exposure could lead to temporary or medically reversible health effects.
Physicians have cautioned that abrupt discontinuation of duloxetine can result in withdrawal symptoms such as depression, fatigue, headaches, and insomnia. Duloxetine, also marketed as Irenka, is a common antidepressant used to treat depression, anxiety, and pain associated with diabetic nerve damage, as well as fibromyalgia. Approximately 18 million prescriptions for the drug are written annually in the U.S.
The drug was manufactured by Towa Pharmaceuticals Europe in Spain and distributed in the U.S. by Breckenridge Pharmaceuticals. N-nitroso-duloxetine can form as a byproduct during the manufacturing process. The FDA has established a safe limit for this chemical in medications at 26.5 nanograms per day.
Experts note that prolonged exposure to elevated levels of nitrosamines, the chemical class to which N-nitroso-duloxetine belongs, may increase cancer risk. Previous animal studies have linked nitrosamines to cancers of the colon and liver.
This recall is not the first instance of Breckenridge Pharmaceuticals recalling antidepressants this year. In April, approximately 165,000 bottles of its 60mg duloxetine delayed-release capsules were recalled for the same chemical contamination issue, affecting 90-count bottles. Earlier in 2024, 7,100 bottles of 20mg duloxetine delayed-release capsules in 500-count bottles were also recalled.
No specific advice has been issued by officials regarding how to handle recalled medication at home, but it is typical for patients to be advised to contact their healthcare providers to discuss alternative treatments.