RecallRadar

FDA Drug recall D-988-2014

OXYBUTYNIN CHLORIDE, Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00603497521

On 2014-01-29 the FDA classified a Class II recall of OXYBUTYNIN CHLORIDE, Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00603497521 by Aidapak Services, citing labeling: Label Mixup: OXYBUTYNIN CHLORIDE, Tablet, 5 mg may have potentially been mislabeled as one of the following drugs: FLECAINIDE ACETATE, Tablet, 100 mg, NDC 00054001125, P….

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-988-2014
ClassificationClass II
Statusterminated
Initiated2013-07-02
Published2014-01-29
Last updated2026-09-13 11:51 UTC
CompanyAidapak Services
DistributionAZ, CA, OR, WA

Product

OXYBUTYNIN CHLORIDE, Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00603497521.

Reason

Labeling: Label Mixup: OXYBUTYNIN CHLORIDE, Tablet, 5 mg may have potentially been mislabeled as one of the following drugs: FLECAINIDE ACETATE, Tablet, 100 mg, NDC 00054001125, Pedigree: AD56847_4, EXP: 5/21/2014; SODIUM CHLORIDE, Tablet, 1 gm, NDC 00223176001, Pedigree: W003792, EXP: 6/27/2014; VARENICLINE, Tablet, 0.5 mg, NDC 00069046856, Pedigree: AD22616_1, EXP: 5/2/2014.

Identifiers

code_info
OXYBUTYNIN CHLORIDE, Tablet, 5 mg has the following codes: Pedigree: AD52778_61, EXP: 5/20/2014; Pedigree: W003898,…OXYBUTYNIN CHLORIDE, Tablet, 5 mg has the following codes: Pedigree: AD52778_61, EXP: 5/20/2014; Pedigree: W003898, EXP: 6/27/2014; Pedigree: AD22616_4, EXP: 5/2/2014.

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-988-2014%22

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