Chantix — Class II drug recall D-0811-2021
Ongoing recall by Pfizer Inc., reported 2021-09-29, distributed nationwide. CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable inta
| Recall number | D-0811-2021 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Pfizer Inc., New York, NY, United States |
| Recall initiated | 2021-08-13 |
| Classified | 2021-09-17 |
| Reported by FDA | 2021-09-29 |
| Distributed | Nationwide (US) |
| Reason classes | cgmp, specification failure |
| NDC | 00069-0469-03 |
| Lot numbers | 00019431, 00019542, 00019543, 00019544, 00020814, 00020815, 00020907, 00020965, 00021421, 00021422, 00021423, 00022136, 00022174, 00022175, 00022176, 00022177, 00022765, 00022766, 00023134, 00023135, 00023747, 00023748, DL3896, DL7779, DR2614, DX4576, DX5870, DX5871, DX5872, DX5873, DX7805, DY6078, DY7060, DY9367, DY9473, DY9475, DY9476, DY9505, EC5910, EC5913 and 8 more |
| Expiration dates | 2021-09-20 |
Product
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
Reason for recall
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0811-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.