On September 17, 2021, the U.S. Food and Drug Administration (FDA) reported Pfizer’s voluntary recall of all lots of varenicline 0.5 mg/1 mg tablets to the patient level because of the presence of N-nitroso-varenicline, a nitrosamine, at or above the FDA interim acceptable intake limit. FDA said that while Pfizer is undertaking the precautionary measure, alternative suppliers have been approved in the United States.
FDA reported Pfizer’s initial recall of 12 lots of varenicline tablets because of N-nitroso varenicline content on July 19, 2021, and Pfizer’s recall expansion to include four additional lots on August 16, 2021.
Long-term ingestion of N-nitroso-varenicline has a theoretical potential to increase cancer risk in humans, but FDA reported no immediate risk to patients taking the medication. FDA added that the health benefits of smoking cessation outweigh the theoretical potential cancer risk from the nitrosamine impurities in varenicline.
The products were distributed nationwide to wholesalers and distributors in the United States, U.S. Virgin Islands, and Puerto Rico from May 2019–September 2021. The recall affects the following lots of varenicline:
Product: Varenicline tablets, 0.5 mg
National Drug Code (NDC): 0069-0468-56
Size: 56-tablet bottle
Expiration Date: January 2022–May 2023
Lot Numbers: 00019213, CY6861, DM9007, DM9008, EC6994, EN5725, EN8362, EN8467
Product: Varenicline tablets, 1 mg
NDC: 0069-0469-56
Size: 56-tablet bottle
Expiration Date: September 2021–December 2023
Lot Numbers: 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, EA6080, EC9841, EC9842, EC9843, EC9847, EC9848, EE1011, EM1069, EM1070, EN5694, EN5695, EP1717, EP1718, EP1719, EW2012, EW3854, EW3865, EX2102, EX2103
Product: Varenicline tablets, 1 mg
NDC: 0069-0469-03
Size: Carton containing four, 14-tablet blister packs
Expiration Date: September 2021–June 2023
Lot Numbers: 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, ET1606
Product: Varenicline tablets, 0.5/1 mg
NDC: 0069-0471-03
Size: Carton containing one blister pack of 11 0.5 mg tablets and one blister pack of 42 1 mg tablets
Expiration Date: August 2021–January 2023
Lot Numbers: 00018522, 00018523, 00018739, 00018740, 00020231, 00020232, 00020357, 00020358, 00020716, 00020813, 00021288, 00021289, 00021420, 00021687, 00021688, 00021788, 00021789, 00021790, 00021791, 00021792, 00022819, 00022851, 00023136, 00023137, 00023190, 00023448, DM0275, DM0276, DM0277, DY4470, EC5911, EC5912, ED6814, ET1600, ET1603, ET1607, ET1609, ET1611
Patients taking Pfizer’s varenicline products should consult their healthcare provider to determine if they have the affected product lots or if alternate treatments are available. Patients with the affected lots should contact Stericycle at 888-276-6166, Monday–Friday, from 8 am–5 pm (ET), for instructions on how to return their product and obtain reimbursement for their cost.
Healthcare professionals with questions regarding the recall can contact Pfizer medical information at 800-438-1985, option 3, Monday–Friday, from 9 am–5 pm (ET). Healthcare professionals can report adverse events and product issues at 800-438-1985.
Healthcare professionals and consumers should report any adverse reactions or quality problems they experienced using the product to MedWatch, FDA’s Safety Information and Adverse Event Reporting Program.