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Drug recall · FDA · Published October 5, 2018

Orexigen Therapeutics, Inc. recalls Contrave (naltrexone HCl and bupropion HCl). Extended-Release Tablets, 8mg/90 mg, 120-count bottles, Rx only,

Orexigen recalls Contrave (naltrexone HCl and bupropion HCl) 8mg/90mg tablets due to container packaging defect. Rx-only 120-count bottles with specific lot number and expiration date.

🇺🇸 FDA recall #D-0219-2019DrugOrexigen ›
Take action

Contact the company & request your remedy

Recalling firmOrexigen Therapeutics, Inc.3344 N Torrey Pines Ct Ste 200 · La Jolla, CA 92037-1024
No email on file for this recall — reach the company by phone or its official page instead.No email on file — write to the address above instead.
✎ GovInfoNow plain-language explainer

What happened, in plain English

Orexigen is recalling Contrave (naltrexone HCl and bupropion HCl) tablets because of a container packaging defect. This could lead to potential issues with the medication's safety or effectiveness. Read more at govinfonow.com/recall/39536-orexigen-contrave-tablets-recall-packaging-defect-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/39536-orexigen-contrave-tablets-recall-packaging-defect-risk · Updated October 6, 2026 · FDA enforcement record: FDA #D-0219-2019

Cite this page

“Orexigen Contrave Tablets Recall: Packaging Defect Risk.” GovInfoNow, updated October 6, 2026. https://govinfonow.com/recall/39536-orexigen-contrave-tablets-recall-packaging-defect-risk. Based on FDA recall #D-0219-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0219-2019%22&limit=1).

Why it’s dangerous

The container packaging defect may cause the medication to be exposed to moisture or air, potentially affecting its stability or effectiveness. This could lead to improper dosing or reduced therapeutic benefits.

Who’s affected

People with prescriptions for Contrave tablets who received the recalled product. Those using the medication as directed are most at risk.

How to tell if you have this one

Check for the product name 'Contrave' with 8mg/90mg tablets in 120-count bottles. The lot number ZYCY and expiration date 04/11/2021 are specific identifiers for this recall.

  • Brand
    Orexigen
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Identify if you have Contrave tablets with the lot number ZYCY and expiration date 04/11/2021.

✎ GovInfoNow

Questions people ask

Is this product safe to use?

The recall is due to a container packaging defect, but the product is safe to use if it has not been exposed to moisture or air. Consult your healthcare provider for guidance.

How can I tell if I have the recalled product?

Look for Contrave 8mg/90mg tablets in 120-count bottles with lot number ZYCY and expiration date 04/11/2021.

What should I do if I have the recalled product?

The recall does not specify a remedy, so contact your healthcare provider for advice on next steps.

Take action

Contact Orexigen

We’ve drafted a message you can send Orexigen to request your refund or repair — edit it as you like.

Subject: Recall D-0219-2019 — Orexigen Orexigen

Hello,

I own a Orexigen that is covered by recall D-0219-2019 from Orexigen.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #D-0219-2019 (October 5, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0219-2019 to see it in context.
  • Plain-language summary written by qwen3:4b on October 6, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA