Antiarrhythmic
Where is Dofetilide made?
13 companies sell it under their own name and 4 repackagers rebottle it. Their labels name 8 factories in India, the United States, Ireland and Italy.
India 4United States 2Ireland 1Italy 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Pfizer Laboratories Div Pfizer Inc Tikosyn0.125 mg, 0.25 mg, 0.5 mg · NDC 0069-5800, 0069-5810, 0069-5820 | Pfizer Ireland Pharmaceuticals Unlimited CompanyMakes the active ingredient and tests it | Ringaskiddy, Ireland | Problems found, fixed voluntarilyOct 2024 |
| Pfizer Italia S.r.l.Makes it, tests it and packages it | Ascoli Piceno, Italy | Problems found, fixed voluntarilyMar 2025 | |
| Accord Healthcare Inc.0.125 mg, 0.25 mg, 0.5 mg · NDC 16729-490, 16729-491, 16729-492 | Intas Pharmaceuticals LimitedMakes it and tests it | Ahmedabad, India | Serious problems, FDA actionDec 2022 |
| Aurobindo Pharma Limited0.125 mg, 0.25 mg, 0.5 mg · NDC 59651-118, 59651-119, 59651-120 | Apl Healthcare LimitedMakes it and tests it | Tirupati, India | Problems found, fixed voluntarilyDec 2025 |
| Caraco Pharmaceutical Laboratories, Ltd.0.125 mg, 0.25 mg, 0.5 mg · NDC 47335-061, 47335-062, 47335-063 | Sun Pharmaceutical Industries LimitedMakes it and tests it | Dadra, India | Problems found, fixed voluntarilyMar 2019 |
| Exelan Pharmaceuticals, Inc.0.125 mg, 0.25 mg, 0.5 mg · NDC 76282-755, 76282-756, 76282-757 | Granules Pharmaceuticals Inc.Makes it, tests it, packages it and labels it | Chantilly, VA, United States | Problems found, fixed voluntarilyApr 2026 |
| Northstar Rx LLC.0.125 mg, 0.25 mg, 0.5 mg · NDC 72603-130, 72603-131, 72603-132 | Sun Pharmaceutical Industries LimitedMakes it and tests it | Dadra, India | Problems found, fixed voluntarilyMar 2019 |
| Novadoz Pharmaceuticals LLC0.125 mg, 0.250 mg, 0.500 mg · NDC 72205-039, 72205-040, 72205-041 | MSN Laboratories Private LimitedMakes it and tests it | Rangareddy District, India | Problems found, fixed voluntarilyDec 2023 |
| SigmaPharm Laboratories, LLC125 ug, 250 ug, 500 ug · NDC 42794-044, 42794-045, 42794-046 | Sigmapharm Laboratories, LLCMakes it and tests it | Bensalem, PA, United States | Problems found, fixed voluntarilyDec 2025 |
| Bionpharma Inc.0.125 mg, 0.25 mg, 0.5 mg · NDC 69452-131, 69452-132, 69452-133 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Dr. Reddy's Laboratories Inc.0.125 mg, 0.25 mg, 0.5 mg · NDC 75907-056, 75907-055, 75907-054 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Granules Pharmaceuticals Inc.0.125 mg, 0.25 mg, 0.5 mg · NDC 70010-024, 70010-025, 70010-026 | The label doesn't name the factory. Plants this company names for other drugs | ||
| The Janz Corporation0.125 mg, 0.25 mg, 0.5 mg · NDC 84280-5125, 84280-5250, 84280-5500 | The label doesn't name the factory. Plants this company names for other drugs | ||
| VGYAAN Pharmaceuticals LLC0.125 mg, 0.25 mg, 0.5 mg · NDC 72664-229, 72664-230, 72664-231 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Dofetilide in bulk and rebottle it, often for mail-order, clinic or hospital pharmacies. If your bottle shows one of these names, open its NDC to see who made the pills inside.
- Avera McKennan Hospital:
69189-5800,69189-5810,69189-5820 - Liberty Bioscience LLC:
71410-300,71410-301,71410-302 - Major Pharmaceuticals:
0904-7522,0904-7523,0904-7524 - Remedyrepack Inc.:
70518-4738,70518-4617
Recalls
- Jul 18, 2023 · Class III · Sun Pharmaceutical Industries Inc
Out of Specification result observed in content uniformity testing - Feb 7, 2023 · Class II · Accord Healthcare, Inc. · 3 recall notices
CGMP Deviations: recalling drug products following an FDA inspection. - Dec 3, 2014 · Class II · Pfizer Inc.
Failed Tablet/Capsule Specifications: Product being recalled due to the potential presence of cracked or broken capsules.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.