Chantix Varenicline Tablets Recalled for N-Nitroso Impurity
Pfizer is recalling specific lots of Chantix (varenicline) 1 mg tablets nationwide due to the presence of N-nitroso-varenicline impurity above FDA's acceptable interim intake limit. The affected lots were distributed nationwide.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 (CGMP deviation) with a chemical impurity above acceptable limits. The source text does not report any illnesses, injuries, or hospitalizations associated with this impurity, and the hazard is related to manufacturing process control rather than an immediate health threat. Class II recalls without reported harm typically score 2 per the rubric.
Plain-English summary
Pfizer Inc. is recalling specific lots of Chantix (varenicline tartrate) 1 mg tablets (56-tablet packages) distributed nationwide. The recall was initiated because these lots contain the impurity N-nitroso-varenicline at levels exceeding FDA's acceptable interim intake limit.
The affected lots include: 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, EC9841, EC9842, EC9847, EC9848, EE1011, EM1069, EM1070, EN5694, EN5695, EP1717, EP1718, EP1719, EW2012, EW3854, EW3865, EX2102, EX2103, with expiration dates between September 2021 and December 2023. The product is manufactured in Ireland and distributed by Pfizer Labs (Division of Pfizer Inc., New York, NY).
Consumers who have a recalled lot of Chantix should consult their healthcare provider or pharmacist before discontinuing use. This is a Class II recall.
The recalled product
- Product
- CHANTIX (VARENICLINE TARTRATE)
- Brand
- CHANTIX
- Manufacturer
- Pfizer Inc.
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 (20)
- Lots 00018777
- 00019289
- 00019593
- 00019682
- 00019846
- 00019977
- 00020295
- 00020448
- 00020458
- 00020480
- 00021024
- 00021073
- 00021074
- CW1565
- CW1566
- CW1567
- CW1568
- CW1569
- CW1570
- CW1571
UPCs (3)
- 0300690469560
- 0300690468563
- 0300690471280
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Pfizer Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
Same brand · CHANTIX
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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
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- ModeratePfizer Chantix Tablets Recalled for N-Nitroso-Varenicline Impurity
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- ModerateCardinal Health Recalls Chantix Tablets Due to Temperature Excursions
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