Urgent Recall: Check Your Duloxetine (Cymbalta) for Toxic Chemical Contamination

N-nitroso-duloxetine, part of the nitrosamine family, has been identified as a potential carcinogen. Nitrosamines can form during the drug manufacturing process or due to chemical degradation, particularly in environments where drugs are improperly stored. According to the FDA, while low levels of nitrosamines are often found in food and water, elevated exposure over extended periods can increase cancer risk.

Duloxetine is commonly used to treat depression, anxiety, and chronic pain conditions like fibromyalgia. The recall is classified as Class II, meaning that while the risks are serious, they are considered medically reversible with appropriate action. 

Affected lot and instructions for patients

The affected lot (220128) contains 500 delayed-release 20mg capsules of duloxetine, manufactured by Towa Pharmaceutical Europe and distributed nationwide. Patients are advised to check their prescription bottles for the lot number and contact their pharmacy if they suspect they have received the contaminated medication. Pharmacies should replace, or refund affected medication and advise on safe disposal.

If you’re taking duloxetine, it’s critical to speak with your healthcare provider before making any changes to your treatment. Abruptly stopping antidepressants like duloxetine can result in withdrawal symptoms such as dizziness, anxiety, or irritability. Your doctor can provide alternative treatment options and ensure a smooth transition to a safe medication.

Why Nitrosamines are a growing concern

This recall is part of a broader issue within the pharmaceutical industry concerning nitrosamine contamination. Over the past few years, the FDA has investigated numerous medications for similar concerns, including blood pressure and heartburn drugs. Nitrosamines form due to the chemical reactions that occur during drug manufacturing or improper storage, and regulators are implementing stricter limits to ensure patient safety.

The FDA continues to work with pharmaceutical companies to understand how nitrosamines are forming and to prevent future contamination. As research continues, patients need to remain informed about drug recalls and to trust their healthcare professionals for guidance.

As the FDA continues to monitor pharmaceutical products for harmful chemicals, patients should stay vigilant and consult healthcare professionals regularly. If you have any concerns about the medications you are taking, reach out to your doctor or pharmacist for reassurance and guidance.

This recall is a reminder of the importance of proper drug regulation and manufacturing standards to protect public health. While the risks associated with this particular recall are medically reversible, taking prompt action is crucial for safeguarding your health.