FDA Expands Recall to Include Four Additional Lots of Varenicline Tablets Because of N-Nitroso Varenicline Content

August 19, 2021

On August 16, 2021, the U.S. Food and Drug Administration (FDA) reported Pfizer’s voluntary recall of an additional four lots of varenicline 0.5mg/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. To date, Pfizer has not received any reports of adverse events that have been related to the recall. FDA reported Pfizer’s recall of 12 lots of varenicline tablets because of N-nitroso varenicline content on July 19, 2021.

FDA Expands Recall to Include Four Additional 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. FDA added that the health benefits of smoking cessation outweigh the theoretical potential cancer risk from the nitrosamine impurities in varenicline.

The product lots were distributed nationwide to wholesalers and distributors in the contiguous United States and Puerto Rico from June 2019June 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

00018522

2021 AUG

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

00018523

2021 AUG

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

00018739

 

2021 AUG

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

00018740

 

2021 AUG

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

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 at 888-276-6166, Monday–Friday, from 8 am–5 pm (ET).

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 consumer should report any adverse reactions or quality problems they experienced using this product to MedWatch, FDA’s Safety Information and Adverse Event Reporting Program.


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