FDA Recall Chantix

View Recall Number, Date, Reasons, Quantity

FDA Recall Enforcement Reports

The last Recall Enforcement Report for Chantix with NDC 0069-0469 was initiated on 08-13-2021 as a Class II recall due to cgmp deviations: presence of the n-nitroso-varenicline impurity above fda s acceptable interim acceptable intake limit The latest recall number for this product is D-0810-2021 and the recall is currently ongoing .

Recall Number Initiation Date Report Date Recall Classification Product Quantity Product Description Status
D-0810-202108-13-202109-29-2021Class IIChantix (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.Ongoing
D-0809-202108-13-202109-29-2021Class IIChantix (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.Ongoing
D-0811-202108-13-202109-29-2021Class IIChantix (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 2023Ongoing
D-0700-202106-09-202108-11-2021Class II350,985 cartonsChantix (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.Ongoing
D-0701-202106-09-202108-11-2021Class II69,6396 bottlesChantix (varenicline) tablets, 1 mg, 56 Tablets, Rx Only, Distributed by Pfizer Labs, Division of Pfizer Inc., NY, NY 10017, Made in Ireland. NDC 0069-0469-56Ongoing
D-0699-202106-09-202108-11-2021Class II59,232 bottlesChantix (varenicline) tablets, 0.5mg*, 56 Tablets, Rx Only, Distributed by Pfizer Labs, Division of Pfizer Inc., NY, NY 10017, Made in Ireland. NDC 0069-0468-56Ongoing
D-0556-202103-15-202106-02-2021Class II1040 cartonsChantix (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 10017Completed
D-0555-202103-15-202106-02-2021Class II848 bottlesChantix (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 0069-0469-56Completed
D-0554-202103-15-202106-02-2021Class II940 cartonsChantix (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 10017Completed

What is the Enforcement Report?

All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.