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.

CONTRAVE (naltrexone HCl and bupropion HCl )extended-release tablets Recalled by Takeda Pharmaceuticals North America, Inc. Due to Failed Tablet/Capsule Specifications: Potential tablet defect of broken...

Date: May 21, 2015
Company: Takeda Pharmaceuticals North America, Inc.
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 Takeda Pharmaceuticals North America, Inc. directly.

Affected Products

CONTRAVE (naltrexone HCl and bupropion HCl )extended-release tablets, 8 mg/ 90 mg, 120-count bottle, Rx only, Manufactured for Orexigen Therapeutics, Inc., La Jolia, CA 92037, Distributed by Takeda Pharmaceuticals America, Inc., Deerfield, IL 60015, NDC 64764-890-99.

Quantity: 3,619 bottles

Why Was This Recalled?

Failed Tablet/Capsule Specifications: Potential tablet defect of broken tablets and/or equatorial splitting of the bilayer tablets into the two drug components.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Takeda Pharmaceuticals North America, Inc.

Takeda Pharmaceuticals North America, Inc. has 1 total recall tracked by RecallDetector.

Related Recalls

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