The U.S. Food and Drug Administration (FDA) has announced a voluntary recall of Chantix (varenicline), a widely used smoking cessation medication, after detecting elevated levels of nitrosamines in certain batches. Nitrosamines, naturally occurring chemical compounds, can increase cancer risk when present at high levels in medications.

Although the exact risk to patients is still under evaluation, the FDA emphasized the need for precaution. The recall, initiated in cooperation with the manufacturer, aims to remove affected lots to ensure safety and maintain public confidence.

Chantix has long been considered one of the most effective aids for quitting smoking, and its temporary shortage may challenge patients currently using the drug. Healthcare providers are advised to contact patients who received recalled products and discuss alternative options.

The FDA is urging drug manufacturers to improve nitrosamine testing industry-wide. While the recall may cause disruption, officials stress it demonstrates the FDA’s commitment to patient safety, even when risks remain uncertain.