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Antidepressant Used by Millions Recalled Over Contamination Fears

The company detected elevated levels of potentially cancer-causing chemicals.

Tamilore OshikanluBreaking News Intern

PublishedJun 17, 2026, 1:56 PM EDT

UpdatedJun 17, 2026, 2:02 PM EDT

Updated Jun 17, 2026, 2:02 PM EDTPublished Jun 17, 2026, 1:56 PM EDT

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Millions of Americans who take a popular antidepressant are being urged to check their medicine cabinets after a staggering number of bottles were recalled amid concerns over possible contamination.

Towa Pharmaceutical and its U.S. distributor, Breckenridge Pharmaceutical, voluntarily recalled multiple lots, totaling nearly 370,000 bottles, of duloxetine delayed-release capsules on June 4.

The voluntary recall came after a potentially cancer-causing chemical, N-nitroso-duloxetine, was discovered in elevated levels above the acceptable limits set by the Food and Drug Administration (FDA).

The recall affects both 30 mg and 60 mg capsules of duloxetine, a widely prescribed medication used to treat depression, anxiety, fibromyalgia, and certain types of chronic nerve pain.

According to the National Library of Medicine, N-nitroso-duloxetine is a nitrosamine compound that is “suspected of causing cancer.” The compound belongs to a broader class of chemicals that have triggered a string of high-profile drug recalls.

Duloxetine is one of the most commonly prescribed antidepressants in the U.S., and is sold separately under the brand name Cymbalta.

The recall affects the generic duloxetine delayed-release capsules manufactured by Towa Pharmaceutical. Cymbalta, which is manufactured by Lilly, is not impacted.

Among those who have publicly discussed taking duloxetine are singer-actress sisters Aly and AJ Michalka, who told PopSugar in 2020 that they had taken Cymbalta for nearly a decade to help manage anxiety, depression, and obsessive-compulsive disorder.

The medication works by increasing levels of serotonin and norepinephrine, brain chemicals that help regulate mood and pain signals.

The FDA has not said what caused the elevated nitrosamine levels in the recalled lots. Such compounds can form during manufacturing, arise from contaminated ingredients, or develop when medications break down over time due to heat, moisture, or interactions with packaging materials.

Federal regulators have classified the action as a Class II recall, the FDA’s second-highest risk category. The designation means exposure to the affected product could cause temporary or medically reversible health consequences, though serious adverse health effects are considered unlikely.

Breckenridge has not received any reports of adverse events linked to the recalled medication.

While the word cancer-causing may alarm patients, health officials stress that nitrosamines are common in everyday life. The FDA states that they are found in water and foods, including grilled and cured meats, vegetables, and dairy products, adding that virtually everyone is exposed to some level of the compounds.

The California State Board of Pharmacy notes that cancer risks are primarily associated with long-term exposure above acceptable limits. A person taking a medication containing nitrosamines at or below the FDA’s daily intake threshold every day for 70 years would not be expected to face an increased cancer risk, according to the agency.

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The recall is not the first involving duloxetine. In 2024, Breckenridge recalled more than 7,000 bottles of the drug over elevated nitrosamine levels.

Similar concerns also prompted Pfizer to recall 12 lots of its smoking-cessation drug Chantix in 2021 after excessive levels of another cancer-causing impurity, N-nitroso-varenicline, were detected.

The FDA advises patients not to stop taking prescription medications with potential nitrosamine impurities without first consulting a healthcare provider. Abruptly discontinuing duloxetine can trigger withdrawal symptoms that may begin within hours and persist for up to six weeks.

Patients with questions about the recall are encouraged to speak with their pharmacist or healthcare provider about replacement medication and other treatment options, according to the FDA.

Tamilore OshikanluBreaking News Intern

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