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