FDA Drug recall D-1206-2015
CONTRAVE (naltrexone HCl and bupropion HCl )extended-release tablets, 8 mg/ 90 mg, 120-count bottle, Rx only, Manufactured for Orexigen The…
- FDA Drug
- Class II
- terminated
- Published 2015-07-08
On 2015-07-08 the FDA classified a Class II recall of CONTRAVE (naltrexone HCl and bupropion HCl )extended-release tablets, 8 mg/ 90 mg, 120-count bottle, Rx only, Manufactured for Orexigen The… by Takeda Pharmaceuticals North America, citing failed Tablet/Capsule Specifications: Potential tablet defect of broken tablets and/or equatorial splitting of the bilayer tablets into the two drug components.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1206-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-05-21 |
| Published | 2015-07-08 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Takeda Pharmaceuticals North America |
| Distribution | US |
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
Failed Tablet/Capsule Specifications: Potential tablet defect of broken tablets and/or equatorial splitting of the bilayer tablets into the two drug components.
Identifiers
| code_info | Lot # B21642; Exp. 03/17 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1206-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.