American Health Packaging Recalls Bupropion 100mg Due to Stability Issues
American Health Packaging recalls 389 cartons of Bupropion Hydrochloride 100mg tablets due to failed stability specifications. Check your lot number.
Use caution until it’s fixed
Failed Stability Specifications; out of specification results at the 9 month stability time point for color, dissolution and related compounds.
Contact the company
What happened, in plain English
American Health Packaging is recalling one lot of Bupropion Hydrochloride Extended Release Tablets, USP 100 mg because they failed stability specifications for color, dissolution, and related compounds at the nine-month mark. The recall affects 389 cartons distributed nationwide. No remedy or return instructions are currently listed in the record. Read more at govinfonow.com/recall/48350-american-health-packaging-recalls-bupropion-hydrochloride-extended-release-tablets-usp.
Source Summary by GovInfoNow · govinfonow.com/recall/48350-american-health-packaging-recalls-bupropion-hydrochloride-extended-release-tablets-usp · Updated October 13, 2026 · FDA enforcement record: FDA #D-892-2013
Cite this page
“American Health Packaging Recalls Bupropion 100mg Due to Stability Issues.” GovInfoNow, updated October 13, 2026. https://govinfonow.com/recall/48350-american-health-packaging-recalls-bupropion-hydrochloride-extended-release-tablets-usp. Based on FDA recall #D-892-2013 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-892-2013%22&limit=1).
Why it’s dangerous
The tablets failed stability specifications for color, dissolution, and related compounds at the nine-month stability time point. This means the chemical composition or physical integrity of the drug may have degraded beyond acceptable limits, potentially affecting its efficacy or safety profile.
Who’s affected
Patients who have been prescribed Bupropion Hydrochloride Extended Release Tablets, USP 100 mg by Actavis South Atlantic LLC and packaged by American Health Packaging. The specific risk is limited to those holding the affected lot number.
How to tell if you have this one
Check if you have a 100-count carton containing 10 blister cards of 10 individually blistered and labeled tablets. Look for NDC 68084-470-01, Lot #114500, Expiration Date 08/2013, and repackaging date 12/04/2011.
- Brand
American Health Packaging- Category
Drug
What to do — step by step
Check Your Medication
Verify if your Bupropion Hydrochloride tablets match the specific lot number, expiration date, and NDC listed in the recall record.
Consult Your Pharmacist
Contact your pharmacist or healthcare provider to discuss whether you should continue taking this medication or switch to a different supply.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 7 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.
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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-892-2013 (February 4, 2013) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-892-2013 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 13, 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.