The U.S. Food and Drug Administration (FDA) has issued a Class II recall for more than 370,000 bottles of duloxetine delayed-release capsules, a commonly prescribed antidepressant. The recall affects 360,000 bottles of 60-milligram (mg) capsules and 14,000 bottles of 30mg capsules, distributed by New Jersey-based Breckenridge Pharmaceuticals. The FDA flagged the recall after tests detected elevated levels of N-nitroso-duloxetine, a probable human carcinogen, in the capsules. No illnesses have been reported, but the agency warned that exposure could cause temporary or reversible health effects.
The recalled drugs, sold under the brand name Cymbalta and others, were manufactured by Towa Pharmaceuticals Europe (Spain) and distributed in the U.S. by Breckenridge. The affected batches have expiration dates up to May 2025. The FDA has not issued specific guidance for patients with the recalled medication, but experts caution against abruptly stopping the drug, which can trigger withdrawal symptoms like depression, fatigue, and insomnia.
Duloxetine is widely prescribed for depression, anxiety, diabetic nerve pain, and fibromyalgia, with approximately 18 million prescriptions annually in the U.S. The recall was announced via FDA notices but has not been accompanied by a press release.