Class II · Moderate risk
Bupropion Hydrochloride Extended-Release Tablets USP
Failed Tablet/Capsule Specifications
buPROPion Hydrochloride Extended-release Tablets USP
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed Dissolution Specifications; the product is dissolving faster than the specified limits.
Cause type: Dissolution failure
The tablet or capsule did not dissolve within specification. Dissolution controls how much drug the body absorbs; a failure can change the effective dose. All dissolution failure recalls.
What was recalled
buPROPion Hydrochloride Extended-release Tablets USP (XL) Once-Daily, 150 mg, 100 Tablets (10 x 10) per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC: 60687-782-01.
Affected NDC
60687-0782-01
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 |
|---|---|---|---|---|
| Bupropion Hydrochloride NDC 60687-0782 |
150 mg/1 | Tablet, Extended Release Oral |
American Health Packaging | Rx |
- Recalling firm
- Amerisource Health Services LLC
- Origin
- OH, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0590-2024 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
Other Bupropion recalls
See all
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
Class II · Moderate risk
BuPROPion Hydrochloride Tablets
Failed Impurities/Degradation Specifications
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Class III · Low risk
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Class II · Moderate risk
Meclizine Hydrochloride Tablets
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