Sun Pharmaceutical recalls 500 mcg Dofetilide capsules due to failed content uniformity. This may affect medication accuracy. Contact for return instructions.
Failed Content Uniformity Specifications
Sun Pharmaceutical is recalling 500 mcg Dofetilide capsules that failed content uniformity tests. This could mean the medication dose isn't consistent, which might affect treatment effectiveness.
The capsules failed content uniformity tests, meaning the actual dose may vary from the labeled amount. This inconsistency could lead to incorrect medication levels in the bloodstream, potentially affecting heart rhythm treatment.
Prescription patients using the recalled capsules. Those with heart conditions requiring precise dosing are most at risk.
Check for the 60-count bottle labeled 'Dofetilide Capsules, 500 mcg (0.5 mg), Rx only'. The product was manufactured by Sun Pharmaceutical Industries Limited in India with NDC 47335-0063-86 and Lot # DND1541A.
Look for the 60-count bottle with NDC 47335-0063-86 and Lot # DND1541A.
The recall is due to failed content uniformity, which may cause inconsistent dosing. The product is not safe for use as recalled.
Check for the 60-count bottle labeled 'Dofetilide Capsules, 500 mcg (0.5 mg), Rx only' with NDC 47335-0063-86 and Lot # DND1541A.
The recall record does not specify a remedy, so contact the manufacturer for instructions.
We’ve drafted a message you can send Sun Pharmaceutical to request your refund or repair — edit it as you like.
Subject: Recall D-0474-2023 — Sun Pharmaceutical Sun Pharmaceutical Hello, I own a Sun Pharmaceutical that is covered by recall D-0474-2023 from Sun Pharmaceutical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
