Pfizer Chantix Tablets Recalled for N-Nitroso-Varenicline Impurity
Pfizer is recalling approximately 350,985 cartons of Chantix (varenicline tartrate) tablets nationwide due to the presence of N-nitroso-varenicline impurity above FDA's acceptable interim intake limit. The recall affects multiple lot numbers with expiration dates ranging from September 2021 to January 2023.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall involving a manufacturing deviation with a chemical impurity. The source text does not report any illnesses, injuries, or hospitalizations associated with the impurity, and the recall is precautionary in nature based on the impurity exceeding an acceptable limit. Per the rubric, Class II recalls without reported illness or injury typically score 2 (Moderate).
Plain-English summary
Pfizer Inc. is recalling Chantix (varenicline tartrate) tablets, a prescription smoking-cessation medication. The recall affects approximately 350,985 cartons distributed nationwide. The product is available in a combination pack containing 0.5 mg tablets for the starting week and 1 mg tablets for continuing weeks.
The recall was initiated due to current good manufacturing practice (CGMP) deviations. Specifically, the recalled batches contain the N-nitroso-varenicline impurity at levels above FDA's acceptable interim intake limit. Affected lot numbers are 00020231, 00020232, 00020357, 00020358, 00020716, ET1600, ET1607, and ET1609, with expiration dates ranging from September 30, 2021 to January 31, 2023. The product was manufactured in Ireland and distributed by Pfizer Labs, Division of Pfizer Inc.
Patients currently taking Chantix from the affected lots should contact their healthcare provider or pharmacist for guidance. Consumers should not discontinue the medication without consulting their doctor. Healthcare providers and patients can report adverse events to FDA's MedWatch program.
The recalled product
- Product
- CHANTIX (VARENICLINE TARTRATE)
- Brand
- CHANTIX
- Manufacturer
- Pfizer Inc.
- Hazard
- impurity-n-nitroso
- manufacturing-deviation
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (15)
- Lots 00020231
- Exp 30 Sept 2021
- 00020232
- Exp 30 Nov 2021
- 00020357
- Exp 31 Dec 2021
- 00020358
- Exp 31
- Jan 2022
- 00020716
- ET1600
- Jan 2023
- ET1607
- Jan 2023 & ET1609
- Jan 2023.
UPCs (3)
- 0300690469560
- 0300690468563
- 0300690471280
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · CHANTIX
- ModeratePfizer recalls Chantix tablets for N-nitroso-varenicline impurity
FDA (Drugs) · 2021-09-29
- ModerateChantix Varenicline Tablets Recalled for N-Nitroso Impurity
FDA (Drugs) · 2021-09-29
- ModeratePfizer Chantix Tablets Recalled for N-nitroso-varenicline Impurity
FDA (Drugs) · 2021-08-11
- ModeratePfizer Chantix Tablets Recalled for Nitroso Impurity Above FDA Limit
FDA (Drugs) · 2021-08-11
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