Class II · Moderate risk
Bupropion Hydrochloride Extended-Release Tablets USP
Failed Tablet/Capsule Specifications
Contrave (naltrexone HCl and bupropion HCl)
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Container packaging defect.
Cause type: Packaging defect
Failed child-resistant closures, leaks, cracked containers, or a defective delivery device. Packaging failures risk accidental exposure (especially to children) or product contamination. All packaging defect recalls.
What was recalled
Contrave (naltrexone HCl and bupropion HCl). Extended-Release Tablets, 8mg/90 mg, 120-count bottles, Rx only, Distributed by Orexigen therapeutics, Inc., La Jolla, CA 92037, NDC 51267-890-99
Affected NDC
51267-0890-99
Compare with the code on your package — it is the most precise check available.
Drug: Bupropion Category: Mental Health Medication
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Contrave Extended-Release naltrexone hydrochloride and bupropion hydrochloride NDC 51267-0890 |
NALTREXONE HYDROCHLORIDE 8 mg/1; BUPROPION HYDROCHLORIDE 90 mg/1 | Tablet, Extended Release Oral |
Nalpropion Pharmaceuticals LLC | Rx |
- Recalling firm
- Orexigen Therapeutics, Inc.
- NDC code
- 51267-890-99
- Origin
- CA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0219-2019 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Bupropion recalls
See all
Class II · Moderate risk
buPROPion Hydrochloride Extended-release Tablets USP
Failed Dissolution Specifications; the product is dissolving faster than the specified limits.
Class II · Moderate risk
buPROPion Hydrochloride Extended-Release Tablets
Presence of Foreign Tablets/Capsules
Class III · Low risk
buPROPion Hydrochloride Extended-Release Tablets
Failed Dissolution Specifications
Class III · Low risk
Bupropion Hydrochloride Extended-Release Tablets USP
Failed Dissolution Specifications
Other recalls by Orexigen Therapeutics, Inc.
All 2018 recalls
Class III · Low risk
Contrave (naltrexone HCl and bupropion HCl)
Defective Container: Customer complaints of punctures in the bottle.
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