Payam Javan: More than 7,000 bottles of Duloxetine Delayed-Release Capsules have been recalled across the United States due to the detection of unsafe levels of a potentially cancer-causing chemical, according to the U.S. Food and Drug Administration (FDA). Manufactured by Towa Pharmaceutical Europe, the recall was initiated on October 10 after the presence of N-nitroso-duloxetine, a nitrosamine impurity, exceeded the FDA’s proposed interim limit. Nitrosamines, like N-nitroso-duloxetine, are known to be toxic if ingested and are suspected carcinogens, raising health concerns.

The FDA notice highlighted that around 7,100 bottles, including 500 20-milligram delayed-release capsules, were affected. The recalled bottles, bearing lot number 220128 with an expiration date of December 2024, have been classified as part of a Class II recall. This means that the drug could cause temporary or medically reversible adverse health effects, though the risk of severe consequences is low. Duloxetine, commonly prescribed to treat depression, anxiety, and chronic pain conditions, is part of a drug class that increases serotonin and norepinephrine levels in the brain.

The exact cause of the nitrosamine impurity in the recalled capsules remains unclear, though the FDA suggests that impurities could arise from the manufacturing process, storage conditions, or chemical reactions within the body. Nitrosamines are commonly found in food and water but can pose a cancer risk with prolonged exposure. The FDA continues to investigate and monitor potential nitrosamine contamination in drugs to ensure consumer safety.