FDA Issues Urgent Nationwide Recall for a

Recall Announcement

The FDA announced a “voluntary recall” of Chantix (varenicline) after testing found

“elevated levels of nitrosamines” in certain batches of the smoking-cessation drug.

Health Concern

Nitrosamines can be harmful at high levels, with long-term exposure linked to cancer.

The FDA said the detected amounts were above the “recommended safety threshold,” prompting precautionary action while risks are evaluated.

Impact on Patients

Chantix is considered highly effective, and its temporary removal may affect those trying to quit smoking.

The FDA advised patients to “should not panic” but to contact healthcare providers to discuss alternatives.

Regulatory Response

The recall, done with the manufacturer, reflects the FDA’s “commitment to safety.”

Officials also urged stronger testing across the industry to maintain confidence in the drug supply.

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