Zydus BuPRODION XL 300mg Tablets Recall: Failed Dissolution Specifications
Zydus Pharmaceuticals USA recalls 300mg BuPRODION XL tablets with failed dissolution specs. These tablets may not release medication properly. Contact for return instructions.
Lower-risk recall
Failed Dissolution Specifications; 6 month time point
Contact the company
What happened, in plain English
Zydus Pharmaceuticals is recalling 300mg BuPRODION XL extended-release tablets that failed dissolution tests. This means the tablets might not release medication as intended, potentially affecting treatment effectiveness. Read more at govinfonow.com/recall/42262-zydus-buprodion-xl-300mg-tablets-recall-failed-dissolution-specifications.
Source Summary by GovInfoNow · govinfonow.com/recall/42262-zydus-buprodion-xl-300mg-tablets-recall-failed-dissolution-specifications · Updated October 9, 2026 · FDA enforcement record: FDA #D-0207-2017
Cite this page
“Zydus BuPRODION XL 300mg Tablets Recall: Failed Dissolution Specifications.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/42262-zydus-buprodion-xl-300mg-tablets-recall-failed-dissolution-specifications. Based on FDA recall #D-0207-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0207-2017%22&limit=1).
Why it’s dangerous
The tablets failed dissolution specifications at the 6-month time point, meaning they may not release medication properly over time. This could lead to inconsistent dosing and treatment effectiveness.
Who’s affected
Prescription patients who received the recalled 300mg BuPRODION XL tablets from Zydus Pharmaceuticals USA. Those with specific batch numbers and expiration dates are most at risk.
How to tell if you have this one
Check for 30-count or 500-count bottles with NDC codes 68382-354-06 or 68382-354-05. The expiration dates range from January 2018 to June 2018.
- Brand
Zydus Pharmaceuticals- Category
Drug
What to do — step by step
Check Product Details
Identify your bottle's NDC code and expiration date to confirm if it's recalled.
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 3.7 years 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-0207-2017 (November 2, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0207-2017 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.