CLASS II Drug recall · Reported 6 Feb 2019 · FDA Enforcement Report
Domperidone per prescription recalled by Duren Health Mart Pharmacy
Duren Health Mart Pharmacy is recalling Domperidone per prescription, distributed in Tennessee. The recall was initiated on 17 Dec 2018 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-0421-2019
- FDA event ID
- 81811
- Recalling firm
- Duren Health Mart Pharmacy, Waynesboro, TN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 Dec 2018
- FDA classified
- 28 Jan 2019
- Reported
- 6 Feb 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Foreign Material
Timeline
| 17 Dec 2018 | Recall initiated by company | |
| 28 Jan 2019 | Classified by FDA | +42 days |
| 6 Feb 2019 | Published 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
Lack of Processing Controls.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
Domperidone 10 mg capsules, 100-count per prescription, Rx only, Duren's Health Mart Pharmacy 215 Dexter Woods Blvd. Waynesboro, TN 38485, NDC 00507-2011-00
Where it was distributed
TN only
Questions about this recall
Why was it recalled?
Lack of Processing Controls.
Which lots are affected?
N/A
Where was it sold?
TN only
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.