Pfizer Expands Varenicline (Chantix) Recall, But Drug Shortages Remain a Concern

Pfizer has expanded its voluntary recall to include all lots of varenicline (Chantix) 0.5 mg and 1 mg tablets, according to a Sept. 17, 2021, FDA press release. This recall is due to the presence of unacceptable N-nitroso-varenicline levels.

However, drug shortages for this drug product are a concern. Therefore, FDA has temporarily exercised regulatory flexibility and discretion for the distribution of the Health Canada-approved Apo-Varenicline tablets in the United States by Apotex, a Canadian pharmaceutical company, that contains N-nitroso-varenicline up to FDA’s interim acceptable intake limit.

This measure is intended to help maintain adequate varenicline supply in the US for the near term. FDA stated in their press release that they won’t object to certain manufacturers distributing varenicline tablets containing N-nitroso-varenicline above FDA’s acceptable intake limit of 37 ng per day but below the interim acceptable intake limit of 185 ng per day until the impurity can be eliminated or reduced to acceptable levels.

Patients taking varenicline from the recalled lots are instructed by FDA to continue taking their current medicine until their pharmacist provides a replacement or their doctor prescribes a different treatment, as they believe the health benefits of stopping smoking outweigh the cancer risk from the nitrosamine impurity in varenicline.

Source: FDA