The Recall Desk
LowFDA (Drugs)·D-0219-2019·Announced 2018-11-14

Orexigen Recalls Contrave Tablets Due to Container Packaging Defect

Orexigen Therapeutics is recalling 18,895 bottles of Contrave extended-release tablets due to a container packaging defect. The affected lot is ZYCY with an expiration date of 04/11/2021.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The FDA classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences. The hazard is limited to a container packaging defect.

Plain-English summary

Orexigen Therapeutics, Inc. is recalling 18,895 bottles of Contrave (naltrexone hydrochloride and bupropion hydrochloride) extended-release tablets. The product is distributed in 120-count bottles and is available by prescription only. The specific lot affected is ZYCY, with an expiration date of 04/11/2021.

The recall was initiated due to a container packaging defect. The agency has classified this recall as Class III, which indicates that the product is not likely to cause adverse health consequences or death.

Consumers who have this specific lot of Contrave should stop using it and contact their healthcare provider or pharmacist for further instructions. The product was distributed within the United States.

The recalled product

Product
CONTRAVE (NALTREXONE HYDROCHLORIDE AND BUPROPION HYDROCHLORIDE)
Brand
CONTRAVE
Affected units
18,895

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot #: ZYCY
  • Exp. 04/11/2021

UPCs (1)

  • 0351267890997

Distribution

Distribution scope not specified by the agency.

Same brand · CONTRAVE