Berkeley Heights, New Jersey — A nationwide recall involving nearly 375,000 bottles of a commonly prescribed antidepressant has been announced after testing found levels of a potentially cancer-causing chemical above what federal regulators consider acceptable.
Breckenridge Pharmaceuticals is recalling multiple lots of duloxetine delayed-release capsules, a generic version of the brand-name medication Cymbalta, after discovering elevated levels of a contaminant known as N-nitroso-duloxetine.
The recall affects both 30mg and 60mg capsule strengths distributed across the United States and remains ongoing.
What Triggered the Recall?
According to the recall notice, the concern centers on the presence of N-nitroso-duloxetine, a member of a group of chemicals known as nitrosamines.
Nitrosamines have been the focus of several major pharmaceutical recalls in recent years, including recalls involving blood pressure medications and the heartburn drug Zantac.
Health experts classify nitrosamines as probable human carcinogens, meaning long-term exposure to elevated levels could potentially increase a person’s risk of developing cancer over time.
The U.S. Food and Drug Administration categorized the action as a Class II recall, indicating that exposure to the affected products may cause temporary or medically reversible health consequences, while the likelihood of serious long-term harm is considered lower.
Breckenridge Pharmaceuticals initiated the recall on June 4.
What Is Duloxetine Used For?
Duloxetine belongs to a class of medications known as serotonin-norepinephrine reuptake inhibitors (SNRIs).
Doctors commonly prescribe the medication to treat:
- Major depressive disorder
- Generalized anxiety disorder
- Fibromyalgia
- Chronic musculoskeletal pain
- Certain types of nerve pain
Because duloxetine affects brain chemistry, healthcare professionals emphasize that patients should never discontinue the medication abruptly without medical guidance.
Suddenly stopping treatment can lead to withdrawal symptoms and other complications.
Patients Advised Not to Stop Medication Suddenly
Medical experts are urging patients who currently take duloxetine to remain calm and contact their healthcare provider if they believe they may have an affected bottle.
Officials stress that patients should not stop taking the medication on their own. Instead, doctors can help determine whether a replacement prescription or alternative treatment option is appropriate.
Pharmacists and healthcare providers are also being advised to inspect inventory and remove affected products from circulation in accordance with FDA guidance.
Which Products Are Included in the Recall?
The recall affects both 30mg and 60mg duloxetine delayed-release capsules distributed by Breckenridge Pharmaceuticals.
Recalled 30mg Capsules
- NDC: 51991-747-10
- Lot Number: 241180C
- Expiration Date: April 2027
- Bottle Size: 1,000 capsules
- Affected Bottles: Approximately 14,729
Recalled 60mg Capsules
- NDC Numbers: 51991-748-90 and 51991-748-10
- Bottle Sizes: 90-count and 1,000-count bottles
- Expiration Dates: November 2026 through May 2027
- Affected Bottles: Approximately 359,676
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The recalled medication was manufactured by Towa Pharmaceutical Europe in Spain and distributed in the United States by Breckenridge Pharmaceuticals.
Growing Attention on Drug Contamination Issues
The latest recall adds to a growing list of pharmaceutical products affected by nitrosamine contamination concerns over the past several years.
Regulators continue to monitor medications for these compounds as manufacturers work to improve quality control and reduce contamination risks during production.
For patients currently taking duloxetine, healthcare providers say the most important step is to verify whether their prescription matches one of the affected lots and discuss any concerns with their doctor or pharmacist before making changes to treatment.
Do you think pharmaceutical companies should face stricter oversight when contamination issues are discovered? Share your thoughts and experiences respectfully in the comments below.
