The Food and Drug Administration (FDA) announced a voluntary recall of a common antidepressant medication taken by millions.
Manufacturer Towa Pharmaceutical and its American distributor, Breckenridge Pharmaceutical, are pulling both the 30mg and 60mg versions of duloxetine delayed-release capsules, which are a generic form of the brand-name drug Cymbalta.
Approximately 370,000 bottles were recalled “due to levels of N-nitroso-duloxetine that exceeded the FDA’s limit,” the New York Post noted.
Antidepressant taken by millions recalled over possible contamination with cancer-causing chemical https://t.co/cGGsa7XFgp pic.twitter.com/o77d4O9w8C
— New York Post (@nypost) June 16, 2026
KVUE explained further:
Duloxetine is an SNRI used to treat depression, anxiety and certain types of chronic pain.
At issue is a chemical called N-nitroso-duloxetine, part of a family of compounds known as nitrosamines. It’s the same type of contaminant that triggered major recalls of blood pressure medications and heartburn drugs like Zantac in recent years. Nitrosamines are classified as probable human carcinogens, meaning repeated exposure above safe levels could raise your risk of cancer over time.
A Class II recall designation indicates that the product “may cause temporary or medically reversible adverse health consequences,” according to the FDA. The company initiated the recall on June 4.
Patients who have been prescribed duloxetine should not stop taking their medication without first consulting their doctor, as abruptly discontinuing the drug can cause withdrawal symptoms.
The recalled medications include:
30mg capsules (NDC 51991-747-10): Lot 241180C, expiring April 2027.
- Packaged in 1,000-capsule bottles. About 14,729 bottles affected.
60mg capsules: Packaged in both 90-count (NDC 51991-748-90) and 1,000-count (NDC 51991-748-10) bottles.
- Multiple lots are affected, with expiration dates ranging from November 2026 through May 2027. About 359,676 bottles affected.
Thousands of bottles of the antidepressant duloxetine have been recalled because they contain levels of a potentially cancer-causing impurity above federal safety limits, according to a notice from the U.S. Food and Drug Administration.https://t.co/PXbNlH1cYw
— ABC News (@ABC) June 16, 2026
More from the New York Post:
Sold under the brand name Cymbalta, it’s a type of selective serotonin and norepinephrine reuptake inhibitor (SNRI) that works to increase serotonin and norepinephrine, hormones that regulate mood and pain, in the brain.
No adverse effects have been reported in connection with the recalled medication, which included multiple bottles across the 30mg and 60mg dosages.
The affected lot codes are 241074C, 240317, 240318, 240315C, 240373C, 240370C, 240375C, 240413C, 240316, 232311, 240978C, 241052C and 241180C.
The recall was classified as Class II, meaning exposure to the product may cause temporary or medically reversible adverse health consequences, while more serious adverse health consequences are remote.
Often found in tobacco products and several pharmaceuticals, nitrosamines are also present in water and some foods, including cured and grilled meats, dairy products, beer and vegetables.
The toxic chemicals form from food when nitrates used as preservatives react with amines, accelerated by high temperatures or stomach acid.
These compounds can appear in medications through chemical reactions during manufacturing, contaminated ingredients or by breaking down due to heat or moisture over time and interaction with packaging.
Read the FDA notice HERE.
