US Drug Recall Register
Class II · Moderate risk Terminated Initiated May 21, 2015 (11 years ago)

Contrave

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

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

What was recalled

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.

Recalling firm
Takeda Pharmaceuticals North America, Inc.
NDC code
64764-890-99
Origin
IL, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-1206-2015

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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