Pharmaceutical companyLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Orexigen Therapeutics with 2 drug recalls and 1 OPDP letter. The most recent is a drug recall dated Oct 5, 2018: Contrave (naltrexone HCl and bupropion HCl). Extended-Release Tablets, 8mg/90 mg, 120-co….
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Oct 5, 2018 | Contrave (naltrexone HCl and bupropion HCl). Extended-Release Tablets, 8mg/90 mg, 120-count bottles, Rx only, Distributed by Orexigen therapClass III · Container packaging defect. | Drug recalls |
| Aug 9, 2018 | Contrave (naltrexone HCl and bupropion HCl) Extended-Release Tablets, 8 mg/90 mg, 120-count bottle, Rx only, Distributed by Orexigen therapeClass III · Defective Container: Customer complaints of punctures in the bottle. | Drug recalls |
| May 18, 2017 | Untitled letter: CONTRAVEOffice of Prescription Drug Promotion | OPDP letters |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built