The U.S. Food and Drug Administration has initiated a voluntary recall of millions of duloxetine delayed-release capsules, a common antidepressant used by hundreds of thousands of Americans. Manufacturer Towa Pharmaceutical and its American distributor, Breckenridge Pharmaceutical, are withdrawing both 30mg and 60mg versions of the generic medication—marketed as a counterpart to the brand-name drug Cymbalta.
The recall affects approximately 370,000 bottles due to elevated levels of N-nitroso-duloxetine, a compound classified as a probable human carcinogen. Nitrosamines, the same contaminants linked to widespread recalls of blood pressure medications and heartburn drugs like Zantac in recent years, pose a cancer risk with repeated exposure above safety thresholds. The FDA designated this as a Class II recall, indicating that while temporary or medically reversible health effects may occur, serious complications are unlikely.
Patients prescribed duloxetine should not abruptly discontinue the medication without consulting their healthcare provider, as sudden cessation can trigger withdrawal symptoms. Affected products include:
– 30mg capsules (NDC 51991-747-10): Lot 241180C, expiring April 2027
– 60mg capsules: NDC 51991-748-90 (90-count) and NDC 51991-748-10 (1,000-count)
The recalled lots span multiple production codes, including 241074C, 240317, 240318, 240315C, 240373C, 240370C, 240375C, 240413C, 240316, 232311, 240978C, 241052C, and 241180C. Nitrosamines naturally form in tobacco products, certain pharmaceuticals, water, cured meats, beer, and vegetables through reactions involving nitrates and amines—often accelerated by heat or stomach acid during manufacturing or storage.
While no adverse effects have been reported for the recalled medication, the FDA emphasizes that repeated exposure to elevated levels of N-nitroso-duloxetine may increase long-term cancer risk. Patients are advised to contact their pharmacies or healthcare providers immediately if they possess affected products.
