Medications & Supplements/Prescription Drugs

Orexigen Therapeutics, Inc.: Contrave Extended-Release Tablets Recalled for Defective Punctured Bottles

Agency Publication Date: August 14, 2018

Summary

Orexigen Therapeutics, Inc. has recalled approximately 95,296 bottles of Contrave (naltrexone HCl and bupropion HCl) Extended-Release Tablets (8 mg/90 mg, 120-count bottles). The recall was initiated following customer complaints of punctures in the medication bottles, which may compromise the integrity of the product. Consumers should contact their healthcare provider or pharmacist regarding this recall and return any unused medication to their pharmacy.

Risk

Punctures in the medicine bottle can expose the tablets to air, moisture, or environmental contaminants, potentially affecting the medication's stability and effectiveness. While the risk is considered low, a compromised container may not properly protect the drug during storage.

What You Should Do

Check your prescription bottle for Contrave (naltrexone HCl and bupropion HCl) Extended-Release Tablets, 8 mg/90 mg in 120-count bottles with NDC 51267-890-99.
Locate the lot number and expiration date on the side of the bottle. Affected lots include ZCXM (Exp 01NOV2020), ZCXN (Exp 02NOV2020), ZCXP (Exp 09NOV2020), ZCXS (Exp 10NOV2020), ZCXT (Exp 13NOV2020), and ZCXV (Exp 17NOV2020).
Inspect the plastic bottle closely for any signs of punctures or holes.
Contact your healthcare provider or pharmacist immediately for guidance if you have one of these affected bottles.
Return any unused product from the affected lots to your pharmacy to receive a refund.
Contact Orexigen Therapeutics, Inc. at their La Jolla, CA office for further information regarding the return process.
For additional questions, 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

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

How to: Return the affected product to the place of purchase for a refund and consult with a medical professional.

Affected Products

Product: Contrave (naltrexone HCl and bupropion HCl) Extended-Release Tablets (120-count bottle)

Model:

NDC 51267-890-99

Recall #: D-1099-2018

Lot Numbers:

ZCXM (Exp 01NOV2020)

ZCXN (Exp 02NOV2020)

ZCXP (Exp 09NOV2020)

ZCXS (Exp 10NOV2020)

ZCXT (Exp 13NOV2020)

ZCXV (Exp 17NOV2020)

Date Ranges: Expiration 01NOV2020, Expiration 02NOV2020, Expiration 09NOV2020, Expiration 10NOV2020, Expiration 13NOV2020, Expiration 17NOV2020

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 80801

Status: Resolved

Manufacturer: Orexigen Therapeutics, Inc.

Sold By: Pharmacies

Manufactured In: United States

Units Affected: 95,296 bottles

Distributed To: Nationwide

Agency Last Updated: August 16, 2018

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

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.

Summary

What You Should Do

Check your prescription bottle for Contrave (naltrexone HCl and bupropion HCl) Extended-Release Tablets, 8 mg/90 mg in 120-count bottles with NDC 51267-890-99.

Locate the lot number and expiration date on the side of the bottle. Affected lots include ZCXM (Exp 01NOV2020), ZCXN (Exp 02NOV2020), ZCXP (Exp 09NOV2020), ZCXS (Exp 10NOV2020), ZCXT (Exp 13NOV2020), and ZCXV (Exp 17NOV2020).

Inspect the plastic bottle closely for any signs of punctures or holes.

Contact your healthcare provider or pharmacist immediately for guidance if you have one of these affected bottles.

Return any unused product from the affected lots to your pharmacy to receive a refund.

Contact Orexigen Therapeutics, Inc. at their La Jolla, CA office for further information regarding the return process.

For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.