FDA Drug recall D-803-2014

VARENICLINE, Tablet, 0.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00069046856

FDA Drug
Class II
terminated
Published 2014-01-29

On 2014-01-29 the FDA classified a Class II recall of VARENICLINE, Tablet, 0.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00069046856 by Aidapak Services, citing labeling: Label Mixup: VARENICLINE, Tablet, 0.5 mg may have potentially been mislabeled as one of the following drugs: LACTOBACILLUS GG, Capsule, 0, NDC 49100036374, Pedigree: W00….

Read the official FDA Drug notice

Agency	FDA Drug
Recall number	D-803-2014
Classification	Class II
Status	terminated
Initiated	2013-07-02
Published	2014-01-29
Last updated	2026-09-13 11:51 UTC
Company	Aidapak Services
Distribution	AZ, CA, OR, WA

Product

VARENICLINE, Tablet, 0.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00069046856.

Reason

Labeling: Label Mixup: VARENICLINE, Tablet, 0.5 mg may have potentially been mislabeled as one of the following drugs: LACTOBACILLUS GG, Capsule, 0, NDC 49100036374, Pedigree: W003051, EXP: 6/12/2014; SOTALOL HCL, Tablet, 160 mg, NDC 00093106201, Pedigree: AD22609_10, EXP: 4/30/2014; VENLAFAXINE HCL, Tablet, 25 mg, NDC 00093019901, Pedigree: AD62796_4, EXP: 5/22/2014.

Identifiers

code_info	VARENICLINE, Tablet, 0.5 mg has the following codes: Pedigree: W003083, EXP: 6/12/2014; Pedigree: AD22616_1, EXP: 5/… VARENICLINE, Tablet, 0.5 mg has the following codes: Pedigree: W003083, EXP: 6/12/2014; Pedigree: AD22616_1, EXP: 5/2/2014; Pedigree: AD62829_1, EXP: 5/22/2014.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-803-2014%22

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