Smoking Cessation Drug Recalled

The presence of an N-nitroso-varenicline impurity above the US Food and Drug Administration (FDA) acceptable daily intake level has prompted Pfizer to voluntarily recall 12 lots of Chantix (varenicline) tablets. The recalls are included in the August 11, 2021, US Food and Drug Administration (FDA) Enforcement Report.

“Long-term ingestion of N-nitroso-varenicline may be associated with a theoretical potential increased cancer risk in humans, but there is no immediate risk to patients taking this medication,” Pfizer stated in a July 16, 2021, company announcement. “The health benefits of stopping smoking outweigh the theoretical potential cancer risk from the nitrosamine impurity in varenicline.”

The recall affects the following Chantix products, which were made in Ireland and distributed throughout the United States:

• Chantix 0.5 mg-tablets in 56-tablet bottles (NDC 0069-0468-56) from lots 00019213 (Exp. 1/31/22) and EC6994 (Exp. 5/31/23);

• Chantix 1-mg tablets in 56-tablet bottles (NDC 0069-0469-56) from lots EC9843 (Exp. 3/31/23) and EA6080 (Exp. 3/31/23); and

• Chantix cartons containing one blister pack of 11 0.5-mg tablets and one blister pack of 42 1-mg tablets (NDC 0069-0471-03) from lots 00020231 (Exp 9/30/21), 00020232 (Exp. 11/30/21), 00020357 (Exp. 12/31/21), 00020358 (Exp 1/31/22), 00020716 (Exp. 1/31/22), ET1600 (Exp. 1/31/23), ET1607 (Exp. 1/31/23), and ET1609 (Exp. 1/31/23).

Pfizer initiated the recall June 9, 2021. On July 30, 2021, the FDA designated the recall Class II, communicating use of the affected drug may cause temporary or medically reversible adverse health consequences or a remote possibility of serious harm.

Chantix is a prescription medication to help patients quit smoking.