> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Pfizer Expands Chantix Recall
- URL: https://www.fdaweb.com/pfizer-expands-chantix-recall/
- Published: 2021-07-20T12:00:00.000Z
- Updated: 2026-09-14T17:07:04.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149748

FDA says Pfizer has expanded its recall of Chantix (varenicline) to 12 lots to the consumer level due to the presence of N-nitroso-varenicline above the company’s acceptable limit for this impurity. The company initially recalled nine lots of the drug 7/2.

An agency [update](https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements-nitrosamine-varenicline-chantix?ref=fdaweb.com) also says FDA is not objecting to certain manufacturers temporarily distributing varenicline tablets containing N-nitroso-varenicline above FDA’s acceptable intake limit of 37 mg/day but below the interim acceptable intake limit of 185 mg/day until the impurity can be eliminated or reduced to acceptable levels.

The notice says Apotex distributes varenicline in Canada under the name Apo-Varenicline. Under this temporary flexibility and discretion, the company can distribute Apo-Varenicline tablets in the U.S. containing N-nitroso-varenicline up to FDA’s interim acceptable intake limit to help maintain adequate varenicline supply in the U.S. for the near term, the notice says.