FDA Drug recall D-0809-2021
Chantix (varenicline) tablets 0.5mg, 56 Tablets, Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc
- FDA Drug
- Class II
- ongoing
- Published 2021-09-29
On 2021-09-29 the FDA classified a Class II recall of Chantix (varenicline) tablets 0.5mg, 56 Tablets, Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc by Pfizer, citing CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0809-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-08-13 |
| Published | 2021-09-29 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Pfizer |
| Distribution | US |
Product
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.
Reason
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
Identifiers
| ndc | 0069-0468-56 |
|---|---|
| ndc | 0069-0469-56 |
| ndc | 0069-0469-28 |
| ndc | 0069-0471-03 |
| ndc | 0069-0471-28 |
| code_info | Lots , CY6861, DM9007, DM9008, EN5725, EN8362, EN8467 EXPIRATION DATE: January 2022 - May 2023 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0809-2021%22
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