CLASS III Drug recall · Reported 22 Aug 2018 · FDA Enforcement Report
Contrave (naltrexone HCl and bupropion HCl) recalled
Orexigen Therapeutics 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 9 Aug 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-1099-2018
- FDA event ID
- 80801
- Recalling firm
- Orexigen Therapeutics, La Jolla, CA
- Brand
- Contrave
- Manufacturer
- Nalpropion Pharmaceuticals LLC
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 9 Aug 2018
- FDA classified
- 16 Aug 2018
- Reported
- 22 Aug 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Antidepressants
Timeline
| 9 Aug 2018 | Recall initiated by company | |
| 16 Aug 2018 | Classified by FDA | +7 days |
| 22 Aug 2018 | 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
Defective Container: Customer complaints of punctures in the bottle.
Product as listed by the FDA
Contrave (naltrexone HCl and bupropion HCl) Extended-Release Tablets, 8 mg/90 mg, 120-count bottle, Rx only, Distributed by Orexigen therapeutics, Inc., La Jolla, CA 92037, NDC 51267-890-99.
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Defective Container: Customer complaints of punctures in the bottle.
Which lots are affected?
Lot #: ZCXM, Exp 01NOV2020; ZCXN, Exp 02NOV2020; ZCXP, Exp 09NOV2020; ZCXS, 10NOV2020; ZCXT, Exp 13NOV2020; and ZCXV, Exp 17NOV2020
Where was it sold?
Nationwide in the USA
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 | Packaging Defects | CA |
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 |