Recall Expanded to Include All Lots of Smoking Cessation Tablets

Pfizer is voluntarily recalling all lots of Chantix (varenicline) 0.5-mg and 1-mg tablets because of the presence of a nitrosamine, N-nitroso-varenicline, at or above the US Food and Drug Administration (FDA) acceptable daily intake level. The latest recalls for the smoking cessation drug were included in the September 29, 2021, 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 September 16, 2021, announcement. “The health benefits of stopping smoking outweigh the theoretical potential cancer risk from the nitrosamine impurity in varenicline.”

Pfizer said it was recalling all Chantix lots as a precautionary measure because alternative varenicline suppliers have been approved in the United States. Over the summer, the company had recalled specific Chantix lots due to the N-nitroso-varenicline impurity.

The latest recall affects the following 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 CY6861, DM9007, DM9008, EN5725, EN8362, and EN8467, which expire between January 2022 and May 2023;
• Chantix 1-mg tablets in 56-tablet bottles (NDC 0069-0469-56) from lots 00018777, 00019289, 00019593, 00019682, 00019846, 00019977, 00020295, 00020448, 00020458, 00020480, 00021024, 00021073, 00021074, CW1565, CW1566, CW1567, CW1568, CW1569, CW1570, CW1571, CW1572, CW1573, CW1574, CW1575, CW1578, CW1579, CW1581, DF5277, DF5278, DF5279, DF5280, DF5281, DF5282, DR5086, DR5092, DR5093, DR5094, DT3885, DW4148, DW4152, DY7987, EC9841, EC9842, EC9847, EC9848, EE1011, EM1069, EM1070, EN5694, EN5695, EP1717, EP1718, EP1719, EW2012, EW3854, EW3865, EX2102, and EX2103, which expire between September 2021 and December 2023; and
• Chantix cartons containing four blister packs of 14 1-mg tablets (NDC 0069-0469-03) from lots 00019431, 00019542, 00019543, 00019544, 00020814, 00020815, 00020907, 00020965, 00021421, 00021422, 00021423, 00022136, 00022174, 00022175, 00022176, 00022177, 00022765, 00022766, 00023134, 00023135, 00023747, 00023748, DL3896, DL7779, DR2614, DX4576, DX5870, DX5871, DX5872, DX5873, DX7805, DY6078, DY7060, DY9367, DY9473, DY9475, DY9476, DY9505, EC5910, EC5913, EE9391, EF2346, EM4805, EM4807, EN2005, ET1601, ET1605, and ET1606, which expire between September 2021 and December 2023.

Pfizer initiated the latest recalls August 13, 2021. The FDA designated the recalls Class II on September 17, 2021. The Class II designation communicates that use of the affected drug may cause temporary or medically reversible adverse health consequences or a remote possibility of serious harm.

“Pfizer believes the benefit/risk profile of Chantix remains positive,” the company stated. “Patients currently taking Chantix should consult with their health care provider about alternative treatment options. To date, Pfizer has not received reports of adverse events assessed to be related to this recall.”