CLASS III Drug recall · Reported 14 Nov 2018 · FDA Enforcement Report
Contrave (naltrexone HCl and bupropion HCl) recalled
Orexigen Therapeutics is recalling Contrave (naltrexone HCl and bupropion HCl). The recall was initiated on 5 Oct 2018 and the FDA has classified it as Class III.
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-0219-2019
- FDA event ID
- 81505
- Recalling firm
- Orexigen Therapeutics, La Jolla, CA
- Brand
- Contrave
- Manufacturer
- Nalpropion Pharmaceuticals LLC
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 5 Oct 2018
- FDA classified
- 6 Nov 2018
- Reported
- 14 Nov 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Antidepressants
Timeline
| 5 Oct 2018 | Recall initiated by company | |
| 6 Nov 2018 | Classified by FDA | +32 days |
| 14 Nov 2018 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Container packaging defect.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Contrave (naltrexone HCl and bupropion HCl). Extended-Release Tablets, 8mg/90 mg, 120-count bottles, Rx only, Distributed by Orexigen therapeutics, Inc., La Jolla, CA 92037, NDC 51267-890-99
Where it was distributed
Within the United States
Questions about this recall
Why was it recalled?
Container packaging defect.
Which lots are affected?
Lot #: ZYCY, Exp. 04/11/2021
Where was it sold?
Within the United States
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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.
More recalls from Orexigen Therapeutics
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Contrave (naltrexone HCl and bupropion HCl) recalledContrave | Orexigen Therapeutics | Other | Nationwide |
Other Naltrexone recalls
All 10| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Naltrexone Hydrochloride Tablets, USP, 50 mg recalledNaltrexone Hydrochloride | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Naltrexone 4.5 mg/mL Suspension, Rx recalled | The Medicine Shoppe Pharmacy | Other | FL |
| Drug | CLASS II | Naltrexone 4.5 mg capsule recalled by MPRX | Mprx | Other | TX |
| Drug | CLASS II | Vivitrol (naltrexone for extended-release injectable recalledVivitrol | Alkermes | Packaging Defects | Nationwide |
| Drug | CLASS II | Vivitrol (naltrexone for extended-release injectable recalledVivitrol | Alkermes | Packaging Defects | Nationwide |