FDA Issues Urgent Nationwide Recall

Recall Announcement

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

after routine testing found “elevated levels of nitrosamines”

in certain batches of the smoking-cessation drug.

Why It Matters

Nitrosamines can be harmful at high levels, with “long-term exposure”

linked to increased cancer risk. The detected amounts were

“above the FDA’s recommended safety threshold,”

prompting precautionary action while risks are still being evaluated.

What the FDA Is Doing

The agency said the recall was initiated “in cooperation with the manufacturer”

to remove affected lots and protect “public confidence in the drug supply.”

It is also urging stronger industry-wide testing for nitrosamines.

Guidance for Patients

Chantix is considered “one of the

most effective medications” to quit smoking,

so disruptions may occur. Patients should “not panic”

but contact healthcare providers to discuss alternatives,

as safety remains the FDA’s “top priority.”

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