Sun Pharmaceutical Dofetilide Capsules Recall: Content Uniformity Testing Issue
Sun Pharmaceutical recalls 500 mcg Dofet: 60-count bottles due to content uniformity testing failures. This may affect medication accuracy. Contact for return instructions.
Lower-risk recall
Out of Specification result observed in content uniformity testing
Contact the company
What happened, in plain English
Sun Pharmaceutical is recalling 500 mcg Dofetilide capsules (60-count bottles) because testing showed inconsistent medication content. This could lead to incorrect dosing if the capsules don't contain the right amount of active ingredient. Read more at govinfonow.com/recall/33238-sun-pharmaceutical-dofetilide-capsules-recall-content-uniformity-testing-issue.
Source Summary by GovInfoNow · govinfonow.com/recall/33238-sun-pharmaceutical-dofetilide-capsules-recall-content-uniformity-testing-issue · Updated August 17, 2026 · FDA enforcement record: FDA #D-1082-2023
Cite this page
“Sun Pharmaceutical Dofetilide Capsules Recall: Content Uniformity Testing Issue.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/33238-sun-pharmaceutical-dofetilide-capsules-recall-content-uniformity-testing-issue. Based on FDA recall #D-1082-2023 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1082-2023%22&limit=1).
Why it’s dangerous
The capsules failed content uniformity testing, meaning the actual medication content may vary from the labeled amount. This could result in incorrect dosing if the capsules don't contain the intended 500 mcg of active ingredient.
Who’s affected
Prescription patients using the recalled capsules. Those with specific medical conditions requiring precise dosing may be at slightly higher risk.
How to tell if you have this one
Check for the 60-count bottle labeled 'Dofetilide Capsules 500 mcg (0.5mg), Rx Only'. The NDC code is 47335-063-86 and lot number DNE0217A, expiring January 2025.
- Brand
Sun Pharmaceutical- Category
Drug
What to do — step by step
Check Product Details
Look for the NDC code 47335-063-86 and lot number DNE0217A on the bottle.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in the USA” 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-1082-2023 (July 18, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1082-2023 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 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.