The FDA has issued a voluntary recall of Chantix (varenicline) after routine checks found “elevated levels of nitrosamines” in certain batches. Nitrosamines can appear naturally in food and water, but higher levels in medicine may pose health risks, including a possible link to cancer. The FDA said the detected amounts were “above the FDA’s recommended safety threshold,” leading regulators to act out of caution.

Although the exact risk to users is still under review, the recall was launched in cooperation with the manufacturer to “ensure both safety and public confidence.” Chantix has long been known as one of the most effective treatments for quitting smoking, so its temporary removal may affect those currently using it for support.

Health providers have been told to contact patients who might have received products from the recalled lots. The FDA advises that patients “should not panic” but instead speak with their doctors about safe alternatives until the medication becomes available again.

The agency also stated that this recall fits into broader efforts to tighten testing standards for nitrosamines, noting that similar problems have appeared in other medications. This push aims to improve drug quality across the industry and prevent future issues.

While the recall may cause inconvenience, officials emphasize that it reflects the FDA’s priority: protecting public health. Even when risks are uncertain or low, taking preventive action helps maintain trust in the safety of medications used by millions.