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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Low RiskFDA Drug
Medications & Supplements/Prescription Drugs

Orexigen Therapeutics, Inc.: Contrave Extended-Release Tablets Recalled for Container Packaging Defect

Agency Publication Date: November 6, 2018
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Summary

Orexigen Therapeutics, Inc. has recalled 18,895 bottles of Contrave (naltrexone HCl and bupropion HCl) extended-release tablets because of a container packaging defect. Contrave is a prescription weight-loss medication, and this specific recall affects 120-count bottles of 8mg/90 mg strength tablets. Consumers should be aware that defects in medication packaging can impact the stability or integrity of the drug. If you have this medication, you should consult with your healthcare provider or pharmacist regarding the continued use of your current supply.

Risk

The packaging defect may compromise the protective seal or structural integrity of the container, potentially exposing the tablets to moisture or environmental factors that could affect how the medication works. While the risk level is currently classified as low, compromised packaging in extended-release medications can lead to sub-optimal treatment outcomes.

What You Should Do

  1. Check your prescription bottle for Contrave (naltrexone HCl and bupropion HCl) Extended-Release Tablets, 8mg/90 mg in 120-count bottles.
  2. Verify if your bottle matches Lot Number ZYCY with an expiration date of 04/11/2021 and NDC number 51267-890-99.
  3. If your medication is part of this recall, contact your healthcare provider or pharmacist for guidance on whether to continue your treatment or obtain a replacement.
  4. Return any unused or affected product to your pharmacy for a refund and contact Orexigen Therapeutics, Inc. at their La Jolla, California office if you have further questions.
  5. For additional information or to report a complaint, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

💰Full Refund

Guidance and refund for unused medication.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Contrave (naltrexone HCl and bupropion HCl) Extended-Release Tablets, 8mg/90 mg (120-count bottles)
Model:
NDC 51267-890-99
Recall #: D-0219-2019
Lot Numbers:
ZYCY (Exp. 04/11/2021)
Date Ranges: 04/11/2021

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 81505
Status: Resolved
Manufacturer: Orexigen Therapeutics, Inc.
Sold By: Pharmacies
Manufactured In: United States
Units Affected: 18,895 bottles
Distributed To: Nationwide

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.