Pfizer Chantix Tablets Recalled for Nitroso Impurity Above FDA Limit
Pfizer is recalling Chantix (varenicline tartrate) 1 mg tablets nationwide because certain lots contain the impurity N-nitroso-varenicline above FDA's acceptable interim intake limit due to manufacturing deviations.
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: The agency classification is FDA Class II. The source text states a manufacturing deviation resulting in an impurity above an acceptable limit, but contains no reports of illness or injury. This is consistent with a precautionary recall based on a quality/manufacturing defect rather than an acute safety threat.
Plain-English summary
Pfizer Inc. is recalling Chantix (varenicline tartrate) 1 mg tablets, 56-tablet bottles, distributed nationwide. The recall affects approximately 69,639 bottles from lots EC9843 (expiration March 31, 2023) and EA6080 (expiration March 31, 2023). The product is made in Ireland and distributed by Pfizer Labs, Division of Pfizer Inc., New York, NY 10017.
The recall was initiated because current Good Manufacturing Practice (cGMP) deviations resulted in the presence of the N-nitroso-varenicline impurity above FDA's acceptable interim intake limit in affected lots.
Consumers who have Chantix from the recalled lots should contact Pfizer or consult their healthcare provider. The product is prescription-only (Rx).
The recalled product
- Product
- CHANTIX (VARENICLINE TARTRATE)
- Brand
- CHANTIX
- Manufacturer
- Pfizer Inc.
- Category
- Drug — Prescription Tablet
- Affected units
- 696,396
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 (6)
- Lots EC9843
- Exp 31
- Mar 2023
- EA6080
- Exp. 31
- Mar 2023.
UPCs (3)
- 0300690469560
- 0300690468563
- 0300690471280
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 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 3 products in this recall →Related recalls
Same brand · CHANTIX
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FDA (Drugs) · 2021-09-29
- ModerateChantix Varenicline Tablets Recalled for N-Nitroso Impurity
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- ModeratePfizer Chantix Tablets Recalled for N-Nitroso-Varenicline Impurity
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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
FDA (Drugs) · 2021-06-02
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Similar recalls
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FDA (Drugs) · 2021-09-29
- ModeratePfizer recalls Chantix tablets for N-nitroso-varenicline impurity
FDA (Drugs) · 2021-09-29
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