Sun Pharmaceutical Buropion Tablets Recall: Failed Dissolution Specifications
Sun Pharmaceutical recalls 150mg bupropion extended-release tablets (60-count) due to failed dissolution specifications. This may affect drug effectiveness. Check NDC 47335-737-86 or UPC 347335737868 for affected products.
Lower-risk recall
Failed Dissolution Specifications
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What happened, in plain English
Sun Pharmaceutical is recalling 150mg bupropion extended-release tablets (60-count bottles) because they failed dissolution specifications. This could mean the medication doesn't work properly as intended. The recall affects prescription-only products sold in the US. Read more at govinfonow.com/recall/42443-sun-pharmaceutical-buropion-tablets-recall-failed-dissolution-specifications.
Source Summary by GovInfoNow · govinfonow.com/recall/42443-sun-pharmaceutical-buropion-tablets-recall-failed-dissolution-specifications · Updated October 9, 2026 · FDA enforcement record: FDA #D-0007-2017
Cite this page
“Sun Pharmaceutical Buropion Tablets Recall: Failed Dissolution Specifications.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/42443-sun-pharmaceutical-buropion-tablets-recall-failed-dissolution-specifications. Based on FDA recall #D-0007-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0007-2017%22&limit=1).
Why it’s dangerous
The tablets failed to dissolve properly in the body, which could lead to inconsistent medication levels. This might not cause serious harm but could reduce effectiveness.
Who’s affected
Prescription patients taking bupropion for depression or anxiety. Those with the specific NDC or UPC codes are most at risk.
How to tell if you have this one
Check for the NDC code 47335-737-86 or UPC 347335737868 on the bottle. The product is a 60-count bottle of 150mg bupropion extended-release tablets, prescription-only.
- Brand
Sun Pharmaceutical- Product
Sun Pharmaceutical Industries, Inc. recalls buPROPion Hydrochloride Extended-release Tablets, USP (SR), 150 mg, Twice-A-Day, in 60 count bottles, Rx only- Category
Drug
What to do — step by step
Check Product Details
Look for the NDC code 47335-737-86 or UPC 347335737868 on the bottle label.
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 22 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-0007-2017 (September 13, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0007-2017 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.