Amerisource Health Services Recalls Bupropion XL 300mg Tablets Due to Dissolution Failure
Amerisource Health Services recalls Bupropion Hydrochloride Extended-Release Tablets (300mg) due to failed dissolution tests in stability samples. This affects specific NDC numbers and requires immediate action.
Lower-risk recall
Failed Dissolution Specifications: The firm was notified that there was a dissolution out of specification result on the 6 month stability samples.
Contact the company
What happened, in plain English
Amerisource Health Services has recalled two types of Bupropion Hydrochloride Extended-Release Tablets (300mg) because lab tests showed the medication didn't dissolve properly over time. This could mean the tablets might not work as intended if taken as prescribed. Read more at govinfonow.com/recall/42275-amerisource-health-services-recalls-bupropion-xl-300mg-tablets-due-to.
Source Summary by GovInfoNow · govinfonow.com/recall/42275-amerisource-health-services-recalls-bupropion-xl-300mg-tablets-due-to · Updated October 9, 2026 · FDA enforcement record: FDA #D-0137-2017
Cite this page
“Amerisource Health Services Recalls Bupropion XL 300mg Tablets Due to Dissolution Failure.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/42275-amerisource-health-services-recalls-bupropion-xl-300mg-tablets-due-to. Based on FDA recall #D-0137-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0137-2017%22&limit=1).
Why it’s dangerous
The tablets failed dissolution tests during stability checks, meaning they might not release the medication properly in the body. This could lead to ineffective treatment if the medication doesn't dissolve correctly as intended.
Who’s affected
People who have the specific 90-count or 500-count bottles with the listed NDC numbers and lot numbers. Those taking this medication for depression or anxiety are most at risk.
How to tell if you have this one
Check for the 90-count or 500-count bottles labeled with NDC 68001-264-05 or 68001-264-03. Also look for lot numbers M601509, M606506, M601510, M604444, or M606515.
- Brand
Amerisource Health Services- Category
Drug
What to do — step by step
Check Product Details
Look for the NDC numbers 68001-264-05 or 68001-264-03 and lot numbers listed above on the bottle.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide and Puerto Rico” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 8 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Is this medication dangerous if taken?
The recall is for potential effectiveness issues, not immediate danger. The medication is still safe to use but may not work as intended.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0137-2017 (October 27, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0137-2017 to see it in context.
- Plain-language summary written by qwen3:4b on October 9, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.