CLASS II Drug recall · Reported 22 Jan 2014 · FDA Enforcement Report
Misoprostol Tablet, 100 mcg recalled by Aidapak Services
Aidapak Services is recalling Misoprostol Tablet, 100 mcg, 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
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-564-2014
- FDA event ID
- 65707
- Recalling firm
- Aidapak Services, Vancouver, WA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 2 Jul 2013
- FDA classified
- 16 Jan 2014
- Reported
- 22 Jan 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Labeling Errors
Timeline
| 2 Jul 2013 | Recall initiated by company | |
| 16 Jan 2014 | Classified by FDA | +198 days |
| 22 Jan 2014 | Published in enforcement report | +6 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; MISOPROSTOL Tablet, 100 mcg may be potentially mislabeled as QUINAPRIL HCL, Tablet, 10 mg, NDC 59762502001, Pedigree: AD42611_4, EXP: 5/14/2014.
Product as listed by the FDA
MISOPROSTOL Tablet, 100 mcg, Rx only, Distributed by: AidaPak Service, LLC, NDC 43386016012
Where it was distributed
Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Questions about this recall
Is Misoprostol Tablet, 100 mcg recalled?
Yes. Aidapak Services recalled Misoprostol Tablet, 100 mcg on 2 Jul 2013. The recall is Class II and its status is Terminated. Recall number D-564-2014.
Why was it recalled?
Labeling: Label Mixup; MISOPROSTOL Tablet, 100 mcg may be potentially mislabeled as QUINAPRIL HCL, Tablet, 10 mg, NDC 59762502001, Pedigree: AD42611_4, EXP: 5/14/2014.
Which lots are affected?
MISOPROSTOL, Tablet, 100 mcg has the following code Pedigree: AD42611_7, EXP: 5/14/2014.
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.
More recalls from Aidapak Services
All 538| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | MERCapsuleTOPURINE, Tablet, 50 mg recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |
| Drug | CLASS II | Selenium, Tablet, 50 mcg, Over The Counter recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |
| Drug | CLASS II | Venlafaxine HCL, Tablet, 100 mg recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |
| Drug | CLASS II | Ascorbic Acid, Tablet, 500 mg, Over The Counter recalled | Aidapak Services | Labeling Errors | 4 states |
| Drug | CLASS II | Calcitriol, Capsule, 25 mcg recalled by Aidapak Services | Aidapak Services | Packaging Defects | 4 states |
Other Misoprostol recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Cytotec (misoprostol) Tablets, 200 mcg , For in-institution use only recalledCytotec | Pfizer | Potency & Assay | Nationwide |