CONTRAVE — Class II drug recall D-1206-2015
Terminated recall by Takeda Pharmaceuticals North America, Inc., reported 2015-07-08, distributed nationwide. Failed Tablet/Capsule Specifications: Potential tablet defect of broken tablets and/or equatorial splitting of
| Recall number | D-1206-2015 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Takeda Pharmaceuticals North America, Inc., Deerfield, IL, United States |
| Recall initiated | 2015-05-21 |
| Classified | 2015-07-02 |
| Reported by FDA | 2015-07-08 |
| Terminated | 2018-02-20 |
| Distributed | Nationwide (US) |
| Quantity | 3,619 bottles |
| NDC | 64764-0890-99 |
| Lot numbers | 03/17, B21642 |
Product
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.
Reason for recall
Failed Tablet/Capsule Specifications: Potential tablet defect of broken tablets and/or equatorial splitting of the bilayer tablets into the two drug components.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1206-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.