Drug Contamination Alert
Breckenridge Pharmaceuticals recalls antidepressant duloxetine due to cancer-causing compound levels exceeding limits.
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Breckenridge Pharmaceutical is recalling nearly 375,000 bottles of duloxetine — a popular generic antidepressant sold under the brand name Cymbalta — after tests found elevated levels of a cancer-causing compound in the capsules. NBC New York reported that the contaminated lots contain high levels of N-nitroso-duloxetine, a nitrosamine impurity that exceeds the FDA's acceptable daily intake limit.
The FDA has classified the action as a Class II recall, meaning the health risk is considered medically reversible or unlikely to cause serious harm. Still, millions of patients who rely on the drug to treat depression, anxiety, and fibromyalgia are now scrambling for alternatives — and doctors warn that stopping the medication abruptly can be dangerous.
Which Bottles Are Affected and Who Made Them
The recall covers 30mg and 60mg delayed-release capsules made by Towa Pharmaceutical Europe, based in Barcelona, Spain. The New Jersey-based distributor Breckenridge Pharmaceutical is coordinating the recall. According to NBC Los Angeles, California patients face a broader impact: two lots of 60mg capsules were flagged specifically for that state.
The 30mg recall includes about 14,729 bottles of 1,000-count capsules from Lot 241180C, which expire in April 2027. The 60mg recall covers roughly 360,000 bottles across multiple lots expiring between November 2026 and May 2027. Breckenridge says it is working with Qualanex LLC to manage product returns.
What Is N-Nitroso-Duloxetine and Why Does It Matter
N-nitroso-duloxetine belongs to a group of chemicals called nitrosamines. These compounds appear naturally in some foods like cured meats. But in medicine, they are tightly regulated because long-term exposure can raise cancer risk. The FDA sets the acceptable limit at roughly 0.83 parts per million for this specific impurity. The recalled capsules tested above that threshold.
This is not the first time nitrosamines have triggered major drug recalls. The heartburn drug Zantac was permanently pulled from shelves in 2020 for the same reason. Blood pressure drug Valsartan faced massive recalls in 2018. Breckenridge itself recalled 7,107 bottles of 20mg duloxetine back in October 2024, making this week's action the largest single wave yet.
Doctors Warn: Do Not Stop Taking This Drug on Your Own
The FDA is urging patients not to quit duloxetine without talking to a doctor first. Stopping the drug suddenly can cause severe withdrawal symptoms — including dizziness, nausea, and so-called "brain zaps" — and can trigger a rapid return of depression or suicidal thoughts. The FDA told CBS MoneyWatch that patients should ask their healthcare provider about "the best course of action."
Psychiatrists describe this as a double-edged sword. The cancer risk from nitrosamine exposure builds over decades of daily use. The withdrawal risk is immediate. Patients who find their prescription unavailable should contact their pharmacy or doctor right away to arrange a safe switch to an unaffected lot or an alternative medication.
A Pattern of Recalls Points to Broader Manufacturing Problems
This recall is part of a string of duloxetine quality failures stretching back to late 2024. Rising Pharmaceuticals recalled 233,003 bottles of 60mg capsules in November 2024. Breckenridge recalled 165,761 more bottles in April 2026 over manufacturing process violations. In December 2025, Breckenridge reached a preliminary class-action settlement over claims that its duloxetine was "economically worthless" due to unsafe impurities.
Industry analysts say the pattern points to systemic quality control failures at overseas manufacturing plants. As of mid-June 2026, pharmacies in several states are reporting supply shortages as recalled stock is pulled from shelves. Patients can check their bottle's NDC number and lot code against the FDA's enforcement database to see if their supply is affected.
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