Cardinal Health Recalls Chantix Tablets Due to Temperature Excursions
Cardinal Health is recalling 1,040 cartons of Chantix (varenicline tartrate) tablets due to intermittent 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, which typically indicates a situation where use of the product might cause temporary or medically reversible health consequences, or where the probability of serious adverse health consequences is remote. The source text does not report any illnesses or injuries, and the hazard is a storage deviation rather than a direct contamination or mislabeling of a high-risk allergen.
Plain-English summary
Cardinal Health Inc. is recalling 1,040 cartons of Chantix (varenicline tartrate) tablets, a prescription medication used for smoking cessation. The recall is being conducted due to Current Good Manufacturing Practice (CGMP) deviations, specifically intermittent exposure to temperature excursions during storage.
The affected product is the Chantix Starting Pack, which contains 11 tablets of 0.5 mg and 42 tablets of 1 mg. The specific lot code is EC5911. The product was distributed in Florida, Georgia, and South Carolina.
Consumers with this product should stop using it and contact their healthcare provider or pharmacist for guidance on next steps. The recall is classified as Class II by the FDA.
The recalled product
- Product
- CHANTIX (VARENICLINE TARTRATE)
- Brand
- CHANTIX
- Manufacturer
- Cardinal Health Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 1,040
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)
- EC5911
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
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 N-nitroso-varenicline Impurity
FDA (Drugs) · 2021-08-11
- ModeratePfizer Chantix Tablets Recalled for Nitroso Impurity Above FDA Limit
FDA (Drugs) · 2021-08-11
Same manufacturer · Cardinal Health Inc.
See all →- HighEnoxaparin syringe bags recalled after being labeled with the wrong strength
FDA (Drugs) · 2025-09-03
- ModerateXolair auto-injectors exposed to temperatures outside labeled storage requirements
FDA (Drugs) · 2025-08-13
- ModerateRecombinate antihemophilic factor vials exposed to temperatures outside labeled storage
FDA (Drugs) · 2025-08-13
- ModerateXolair 75 mg syringes exposed to temperatures outside labeled storage requirements
FDA (Drugs) · 2025-08-13
- ModerateWegovy injection recalled due to temperature exposure during shipping
FDA (Drugs) · 2025-05-07
Same hazard · temperature excursion
See all →- ModerateCyclophosphamide injection vials recalled after a transportation temperature excursion
FDA (Drugs) · 2025-09-24
- ModerateProlia prefilled syringes recalled after potential temperature excursions during transit delays
FDA (Drugs) · 2025-07-30
- ModerateBenlysta vials recalled after potential temperature excursions during transit delays
FDA (Drugs) · 2025-07-30
- ModerateEvenity prefilled syringes recalled after potential temperature excursions during transit delays
FDA (Drugs) · 2025-07-30