CLASS II Drug recall · Reported 29 Jan 2014 · FDA Enforcement Report

DULoxetine HCl DR, Capsule, 20 mg recalled by Aidapak Services

Aidapak Services is recalling DULoxetine HCl DR, Capsule, 20 mg, distributed in Arizona, California, Oregon, Washington. The recall was initiated on 2 Jul 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesDULoxetine HCl DR, Capsule, 20 mg has the following codes: Pedigree: AD30140_31, EXP: 5/7/2014; Pedigree: AD54587_4, EXP: 5/21/2014; Pedigree: AD70585_16, EXP: 5/29/2014; Pedigree: W003506, EXP: 6/21/2014; Pedigree: AD60272_61, EXP: 5/22/2014; Pedigree: AD21790_49, EXP: 5/1/2014; Pedigree: W003005, EXP: 6/11/2014; Pedigree: W003486, EXP: 6/20/2014.
Quantity recalled600 Capsules

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number
D-766-2014
FDA event ID
65690
Recalling firm
Aidapak Services, Vancouver, WA
Classification
Class II
Status
Terminated
Recall initiated
2 Jul 2013
FDA classified
20 Jan 2014
Reported
29 Jan 2014
Type
Voluntary: Firm initiated
Customers notified by
Telephone
Reason category
Packaging Defects
Drug class
Antidepressants

Timeline

2 Jul 2013Recall initiated by company
20 Jan 2014Classified by FDA+202 days
29 Jan 2014Published in enforcement report+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Labeling: Label Mixup: DULoxetine HCl DR, Capsule, 20 mg, may be potentially mis-labeled with one of the following drugs: ENTECAVIR, Tablet, 0.5 mg, NDC 00003161112, Pedigree: AD30140_28, EXP: 5/7/2014; CALCIUM ACETATE, Capsule, 667 mg, NDC 00054008826, Pedigree: AD54587_1, EXP: 5/21/2014; FLUoxetine HCl, Capsule, 10 mg , NDC 16714035103, Pedigree: AD70585_13, EXP: 5/29/2014; CHOLECALCIFEROL

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

DULoxetine HCl DR, Capsule, 20 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00002323560.

Where it was distributed

Repacked drugs were distributed in Arizona, California, Oregon, and Washington.

ArizonaCaliforniaOregonWashington

Questions about this recall

Is DULoxetine HCl DR, Capsule, 20 mg recalled?

Yes. Aidapak Services recalled DULoxetine HCl DR, Capsule, 20 mg on 2 Jul 2013. The recall is Class II and its status is Terminated. Recall number D-766-2014.

Why was it recalled?

Labeling: Label Mixup: DULoxetine HCl DR, Capsule, 20 mg, may be potentially mis-labeled with one of the following drugs: ENTECAVIR, Tablet, 0.5 mg, NDC 00003161112, Pedigree: AD30140_28, EXP: 5/7/2014; CALCIUM ACETATE, Capsule, 667 mg, NDC 00054008826, Pedigree: AD54587_1, EXP: 5/21/2014; FLUoxetine HCl, Capsule, 10 mg , NDC 16714035103, Pedigree: AD70585_13, EXP: 5/29/2014; CHOLECALCIFEROL

Which lots are affected?

DULoxetine HCl DR, Capsule, 20 mg has the following codes: Pedigree: AD30140_31, EXP: 5/7/2014; Pedigree: AD54587_4, EXP: 5/21/2014; Pedigree: AD70585_16, EXP: 5/29/2014; Pedigree: W003506, EXP: 6/21/2014; Pedigree: AD60272_61, EXP: 5/22/2014; Pedigree: AD21790_49, EXP: 5/1/2014; Pedigree: W003005, EXP: 6/11/2014; Pedigree: W003486, EXP: 6/20/2014.

Where was it sold?

Repacked drugs were distributed in Arizona, California, Oregon, and Washington.

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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