# FDA recall D-1206-2015

> **Takeda Pharmaceuticals North America, Inc.** · Class II · drug recall initiated 2015-05-21.

## 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.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-1206-2015
- **Recalling firm:** Takeda Pharmaceuticals North America, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2015-05-21
- **Report date:** 2015-07-08
- **Termination date:** 2018-02-20

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Deerfield, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1206-2015

## Citation

> AI Analytics. FDA recall D-1206-2015. Retrieved 2026-05-27 from https://api.ai-analytics.org/recall/D-1206-2015. Source: US FDA. Licensed CC0.

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