Jeffreys Drug Store Domperidone capsules Recall: FDA Class I

Why it was recalled

Marketed without an approved NDA/ANDA for which safety and efficacy has not been established.

Product description

Domperidone capsules 10 mg, compounded, dispensed in 60, 90, and 360 count bottles, Jeffreys Drug Store 1 North Central Ave. Canonsburg, PA

Lot numbers, UPCs & expiration codes

Lot #: 071116-103323, Exp. Date 1/7/2017

Where it was sold

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-0494-2017
Classification: Class I
Status: Terminated
Recall initiated: Nov 23, 2016
FDA report date: Mar 8, 2017
Quantity: 9 - 30 day scripts
Recall type: Voluntary: Firm initiated
Recalling firm: Jeffreys Drug Store

Original FDA data

Every field from FDA enforcement report D-0494-2017, exactly as published.

Show all FDA fields

City: Canonsburg
State: PA
Status: Terminated
Country: United States
Event ID: 75741
Address: 1 N Central Ave
Code information: Lot #: 071116-103323, Exp. Date 1/7/2017
Postal code: 15317-1301
Report date: Mar 8, 2017
Product type: Drugs
Recall number: D-0494-2017
Classification: Class I
Recalling firm: Jeffreys Drug Store
Product quantity: 9 - 30 day scripts
Termination date: Oct 29, 2018
Reason for recall: Marketed without an approved NDA/ANDA for which safety and efficacy has not been established.
Voluntary / mandated: Voluntary: Firm initiated
Product description: Domperidone capsules 10 mg, compounded, dispensed in 60, 90, and 360 count bottles, Jeffreys Drug Store 1 North Central Ave. Canonsburg, PA
Distribution pattern: PA
Recall initiation date: Nov 23, 2016
Initial firm notification: Letter
Center classification date: Feb 27, 2017

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0494-2017, published Mar 8, 2017. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

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Jeffreys Drug Store Domperidone capsules 10 mg Recall

Summary