Pfizer Widens Chantix Recall Caused by Nitrosamine Contamination

Pfizer has broadened its recall of its smoking cessation drug Chantix (varenicline) to include all 0.5 and 1 mg products because of elevated levels of a nitrosamine contaminant.

But both Pfizer and the FDA said the drug doesn’t pose any immediate danger to patients and, in fact, the benefits of taking it short-term for smoking cessation far outweigh any potential risks from nitrosamine exposure.

The recalled products were distributed nationwide in the U.S., the U.S. Virgin Islands and Puerto Rico from May 2019 to September 2021. Wholesalers and distributors should stop the use and distribution of the tablets immediately, the company said.

Patients shouldn’t experience any drug shortages from the action as the FDA is also allowing Apotex, a Canadian distributor of varenicline, to distribute its brand, Apo-Vareniclin, in the U.S. until the situation is resolved.