Cardinal Health Recalls Chantix Tablets Due to Temperature Excursions
Cardinal Health is recalling 848 bottles of Chantix (varenicline tartrate) tablets due to intermittent exposure to temperature excursions during storage.
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: The recall is classified as FDA Class II, but the source text does not report any illnesses, injuries, or hospitalizations, and the hazard is a storage deviation rather than a confirmed contamination or defect causing harm.
Plain-English summary
Cardinal Health Inc. is recalling 848 bottles of Chantix (varenicline tartrate) tablets, 1 mg, 56-count continuing month boxes. The recall is due to intermittent exposure to temperature excursions during storage, which constitutes a Current Good Manufacturing Practice (CGMP) deviation.
The affected product is distributed in Florida, Georgia, and South Carolina. The specific lot code for the recalled product is EM1069. The product is a prescription-only medication manufactured by Pfizer Labs Division of Pfizer, Inc.
Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for guidance. The recall is classified as FDA Class II, indicating a reasonable probability that use of the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- CHANTIX (VARENICLINE TARTRATE)
- Brand
- CHANTIX
- Manufacturer
- Cardinal Health Inc.
- Category
- Drug — Prescription Medication
- Affected units
- 848
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 (1)
- EM1069
UPCs (3)
- 0300690469560
- 0300690468563
- 0300690471280
Distribution
Part of a larger recall action
This product is one of 198 recalled by Cardinal Health 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 198 products in this recall →Related recalls
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- ModeratePfizer Chantix Tablets Recalled for Nitroso Impurity Above FDA Limit
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- ModeratePfizer Chantix Tablets Recalled for N-Nitroso-Varenicline Impurity
FDA (Drugs) · 2021-08-11
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