Recalls / Generics / Varenicline Tartrate

Varenicline Tartrate

8 FDA drug recalls involving generic “Varenicline Tartrate”.

Date	Class	Product	Firm
2025-11-11	Class III	Varenicline Tablets, 1mg, 56 Tablets, Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540	Dr. Reddy's Laboratories, Inc.
2021-08-13	Class II	Chantix (varenicline) tablets 1 mg, 56 Tablets, Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc.	Pfizer Inc.
2021-08-13	Class II	Chantix (varenicline) tablets 0.5mg, 56 Tablets, Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc.	Pfizer Inc.
2021-06-09	Class II	Chantix (varenicline) tablets, 1 mg, 56 Tablets, Rx Only, Distributed by Pfizer Labs, Division of Pfizer Inc.,	Pfizer Inc.
2021-06-09	Class II	Chantix (varenicline)Tablets, Contains: 1 Starting Week (0.5 mg* x 11 tablets), 3 Continuing Weeks (1 mg x 42	Pfizer Inc.
2021-06-09	Class II	Chantix (varenicline) tablets, 0.5mg*, 56 Tablets, Rx Only, Distributed by Pfizer Labs, Division of Pfizer Inc	Pfizer Inc.
2021-03-15	Class II	Chantix (varenicline) Tablets Starting Pack Contains: 1 Starting Week (0.5 mgx11 tablets) 3 Continuing Weeks (	Cardinal Health Inc.
2021-03-15	Class II	Chantix (varenicline) Tablets Continuing Month Box Contains: 4 Continuing Weeks (1 mg x 56 tablets) Rx only ;	Cardinal Health Inc.