CLASS II Drug recall · Reported 8 Jul 2015 · FDA Enforcement Report
Contrave (naltrexone HCl and bupropion HCl recalled
Takeda Pharmaceuticals North America is recalling Contrave (naltrexone HCl and bupropion HCl )extended-release tablets, 8 mg/ 90 mg, distributed nationwide in the US. The recall was initiated on 21 May 2015 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1206-2015
- FDA event ID
- 71516
- Recalling firm
- Takeda Pharmaceuticals North America, Deerfield, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 21 May 2015
- FDA classified
- 2 Jul 2015
- Reported
- 8 Jul 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Antidepressants
Timeline
| 21 May 2015 | Recall initiated by company | |
| 2 Jul 2015 | Classified by FDA | +42 days |
| 8 Jul 2015 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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.
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Failed Tablet/Capsule Specifications: Potential tablet defect of broken tablets and/or equatorial splitting of the bilayer tablets into the two drug components.
Which lots are affected?
Lot # B21642; Exp. 03/17
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.