FDA Announces Recall for 12 Lots of Varenicline Tablets Because of N-Nitroso Varenicline Content

July 22, 2021

On July 19, 2021, the U.S. Food and Drug Administration (FDA) reported (https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/pfizer-issues-voluntary-nationwide-recall-twelve-lots-chantixr-varenicline-tablets-due-n-nitroso?utm_medium=email&utm_source=govdelivery) Pfizer’s voluntary recall of two lots of varenicline 0.5 mg tablets, two lots of varenicline 1 mg tablets, and eight lots of a varenicline kit of 9.5 mg/1 mg tablets to the patient level because of the presence of N-nitroso-varenicline, a nitrosamine, above the Pfizer-established acceptable daily intake level. Varenicline is a treatment to help patients quit smoking and is intended for short-term use. To date, Pfizer has not received any reports of adverse events that have been related to the recall.

FDA Announces Recall for 12 Lots of Varenicline Tablets Because of N-Nitroso Varenicline Content

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. It added that the health benefits of stopping smoking outweigh the theoretical potential cancer risk from nitrosamine impurities in varenicline.

The product lots were distributed nationwide to wholesalers and distributors from June 2019–June 2021. The national drug code (NDC), lot number, expiration date, and configuration details for varenicline tablets are shown in the following table:

Product NDC Lot Number Expiration Date Presentation Configuration/Count
Varenicline
tablets, 0.5 mg
0069-0468-56 00019213 2022 JAN Bottles 56 tablets per bottle
Varenicline
tablets, 0.5 mg
0069-0468-56 EC6994 2023 MAY Bottles 56 tablets per bottle
Varenicline
tablets, 1 mg
0069-0469-56 EA6080 2023 MAR Bottles 56 tablets per bottle
Varenicline
tablets, 1 mg
0069-0469-56 EC9843 2023 MAR Bottles 56 tablets per bottle
Varenicline
tablets, 0.5/1 mg
0069-0471-03 00020231 2021 SEP Cartons containing two blister packs Carton containing one 11-tablet blister pack of 0.5 mg drug and one 42-tablet blister pack of 1 mg drug
Varenicline
tablets, 0.5/1 mg
0069-0471-03 00020232 2021 NOV Cartons containing two blister packs Carton containing one 11-tablet blister pack of 0.5 mg drug and one 42-tablet blister pack of 1 mg drug
Varenicline
tablets, 0.5/1 mg
0069-0471-03 00020357 2021 DEC Cartons containing two blister packs Carton containing one 11-tablet blister pack of 0.5 mg drug and one 42-tablet blister pack of 1 mg drug
Varenicline
tablets, 0.5/1 mg
0069-0471-03 00020358 2022 JAN Cartons containing two blister packs Carton containing one 11-tablet blister pack of 0.5 mg drug and one 42-tablet blister pack of 1 mg drug
Varenicline
tablets, 0.5/1 mg
0069-0471-03 00020716 2022 JAN Cartons containing two blister packs Carton containing one 11-tablet blister pack of 0.5 mg drug and one 42-tablet blister pack of 1 mg drug
Varenicline
tablets, 0.5/1 mg
0069-0471-03 ET1600 2023 JAN Cartons containing two blister packs Carton containing one 11-tablet blister pack of 0.5 mg drug and one 42-tablet blister pack of 1 mg drug
Varenicline
tablets, 0.5/1 mg
0069-0471-03 ET1607 2023 JAN Cartons containing two blister packs Carton containing one 11-tablet blister pack of 0.5 mg drug and one 42-tablet blister pack of 1 mg drug
Varenicline
tablets, 0.5/1 mg
0069-0471-03 ET1609 2023 JAN Cartons containing two blister packs Carton containing one 11-tablet blister pack of 0.5 mg drug and one 42-tablet blister pack of 1 mg drug

Patients taking varenicline tablets should consult their healthcare provider or pharmacy to determine if they have the affected product lots. Patients with the affected lots should contact Stericycle Inc. at 888-276-6166, Monday–Friday, from 8 am–5 pm (ET).

Healthcare professionals with questions regarding this recall can contact Pfizer medical information at 800-438-1985, 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 (https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home) they experienced using this product to MedWatch, FDA’s Safety Information and Adverse Event Reporting Program.


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