Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Aripiprazole Tablets Recalled by The Harvard Drug Group Due to Failed Dissolution Specifications: Out of specification for dissolution.

Date: November 18, 2020
Company: The Harvard Drug Group
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact The Harvard Drug Group directly.

Affected Products

Aripiprazole Tablets, USP, 15 mg, 30 tablets per unit dose carton, Rx Only, Manufactured by: Apotex, Inc, Toronto, Ontario Canada M9L 1T9, Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152 USA, NDC 0904-6512-04

Quantity: 841 cartons

Why Was This Recalled?

Failed Dissolution Specifications: Out of specification for dissolution.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About The Harvard Drug Group

The Harvard Drug Group has 45 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report