FDA Recall Chantix
View Recall Number, Date, Reasons, Quantity
FDA Recall Enforcement Reports
The most recent Recall Enforcement Report that covers this product was initiated on August 13th, 2021 and classified as a Class II recall due to cgmp deviations: presence of the n-nitroso-varenicline impurity above fda s acceptable interim acceptable intake limit This recall is currently ongoing, and the associated recall number is recall number is D-0810-2021. It pertains to Chantix identified by 0069-0471.
| Recall Number | Recall Initiation Date | Report Date | Quantity | Product Description | Recall Reason | Status |
|---|---|---|---|---|---|---|
| D-0810-2021 | 08-13-2021 | 09-29-2021 | Chantix (varenicline) tablets 1 mg, 56 Tablets, Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc. NY, NY 10017, Made in Ireland, NDC 0069-0469-56. | CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit | Ongoing | |
| D-0809-2021 | 08-13-2021 | 09-29-2021 | Chantix (varenicline) tablets 0.5mg, 56 Tablets, Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc. NY, NY 10017, Made in Ireland, NDC 0069-0468-56. | CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit | Ongoing | |
| D-0811-2021 | 08-13-2021 | 09-29-2021 | Chantix (varenicline) tablets 1 mg, Carton containing 4 blister packs of 14 tablets each,, Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc. NY, NY 10017, Made in Ireland, NDC 0069-0469-03. EXPIRATION DATE: September 2021 June 2023 | CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit | Ongoing | |
| D-0701-2021 | 06-09-2021 | 08-11-2021 | 69,6396 bottles | Chantix (varenicline) tablets, 1 mg, 56 Tablets, Rx Only, Distributed by Pfizer Labs, Division of Pfizer Inc., NY, NY 10017, Made in Ireland. NDC 0069-0469-56 | CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDAs acceptable interim acceptable intake limit | Ongoing |
| D-0699-2021 | 06-09-2021 | 08-11-2021 | 59,232 bottles | Chantix (varenicline) tablets, 0.5mg*, 56 Tablets, Rx Only, Distributed by Pfizer Labs, Division of Pfizer Inc., NY, NY 10017, Made in Ireland. NDC 0069-0468-56 | CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit | Ongoing |
| D-0700-2021 | 06-09-2021 | 08-11-2021 | 350,985 cartons | Chantix (varenicline)Tablets, Contains: 1 Starting Week (0.5 mg* x 11 tablets), 3 Continuing Weeks (1 mg x 42 tablets), Rx Only, Distributed by Pfizer Labs, Division of Pfizer Inc, NY, NY 10017, Made in Ireland, NDC 0069-0471-03. | CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDAs acceptable interim acceptable intake limit | Ongoing |
| D-0556-2021 | 03-15-2021 | 06-02-2021 | 1040 cartons | Chantix (varenicline) Tablets Starting Pack Contains: 1 Starting Week (0.5 mgx11 tablets) 3 Continuing Weeks (1 mgx42 tablets) Rx only NDC 0069-0471-03 Distributed by Pfizer Labs Division of Pfizer, Inc., NY, NY 10017 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Terminated |
| D-0555-2021 | 03-15-2021 | 06-02-2021 | 848 bottles | Chantix (varenicline) Tablets Continuing Month Box Contains: 4 Continuing Weeks (1 mg x 56 tablets) Rx only ; Rx only Distributed by Pfizer Labs Division of Pfizer, Inc., NY, NY ,10017NDC 0069-0469-56 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Terminated |
| D-0554-2021 | 03-15-2021 | 06-02-2021 | 940 cartons | Chantix (varenicline) Tablets Continuing Month Box Contains: 4 Continuing Weeks (1 mg x 56 tablets) Rx only NDC 0069-0469-03 Distributed by Pfizer Labs Division of Pfizer Inc., NY, NY 10017 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Terminated |
What is a Recall Enforcement Report?
A Recall Enforcement Report is an official publication by the FDA that documents all classified drug recalls.
When a company initiates a product removal or correction, the FDA evaluates whether the action meets the criteria for a recall. If it does, the FDA assesses the level of public health risk and assigns a recall classification (Class I, II, or III). Once classified, the recall is published in the Enforcement Report, which includes details such as the product name, affected lot numbers, reason for recall, and scope of distribution.
The Enforcement Report ensures transparency and allows the public and healthcare professionals to stay informed about products that may present a health or safety concern.
Understanding Recall Reports
The recall information provided on this website is sourced directly from official U.S. Food and Drug Administration (FDA) data. It is important to understand that most product recalls are limited in scope and typically involve only specific lots or batches of a product that have been identified as potentially defective or non-compliant with regulatory standards.
Recalls may be initiated voluntarily by the manufacturer or distributor, or they may be mandated by the FDA when a product is found to pose a health risk. A recall does not necessarily mean that all units of a product are unsafe.
If you have concerns about the safety of a medication or healthcare product you are using, it is strongly recommended that you verify the product’s lot number and consult your pharmacist or healthcare provider to determine whether your specific product is affected by the recall.
