Antiarrhythmic
Where is Propafenone made?
10 companies sell it under their own name and 7 repackagers rebottle it. Their labels name 7 factories in India, the United States and China.
India 5United States 1China 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Aurobindo Pharma Limited150 mg, 225 mg, 300 mg, 325 mg, 425 mg · NDC 59651-256, 59651-257, 59651-276 +3 | Aurobindo Pharma LimitedMakes it and tests it | Medchal, India | Problems found, fixed voluntarilyJul 2023 |
| Aurobindo Pharma LimitedMakes it and tests it | Mahabubnagar, India | Problems found, fixed voluntarilyMay 2022 | |
| Cadila Healthcare Limited225 mg, 325 mg, 425 mg · NDC 70771-1525, 70771-1526, 70771-1527 | Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | Problems found, fixed voluntarilyMar 2023 |
| Glenmark Pharmaceuticals Inc., USA225 mg, 325 mg, 425 mg · NDC 68462-408, 68462-409, 68462-410 | Glenmark Pharmaceuticals LimitedMakes it and tests it | Dhar, India | Serious problems, FDA actionFeb 2025 |
| Northstar Rx LLC.225 mg, 325 mg, 425 mg · NDC 16714-825, 16714-826, 16714-827 | Glenmark Pharmaceuticals LimitedMakes it and tests it | Dhar, India | Serious problems, FDA actionFeb 2025 |
| Rising Pharma Holdings, Inc.225 mg, 325 mg, 425 mg · NDC 16571-736, 16571-737, 16571-738 | USV Private LimitedMakes it, tests it, packages it and labels it | Daman, India | Serious problems, FDA actionApr 2026 |
| Upsher-Smith Laboratories, Inc.225 mg, 325 mg, 425 mg · NDC 0832-0740, 0832-0741, 0832-0742 | Bora Pharmaceuticals Inc.Makes it and tests it | Maple Grove, MN, United States | Problems found, fixed voluntarilyAug 2022 |
| Vitruvias Therapeutics, Inc.225 mg, 325 mg, 425 mg · NDC 69680-130, 69680-131, 69680-132 | Haimen Pharma Inc.Makes it, tests it, packages it and labels it | Nantong, China | Problems found, fixed voluntarilyAug 2023 |
| Zydus Pharmaceuticals (USA) Inc.225 mg, 325 mg, 425 mg · NDC 68382-522, 68382-523, 68382-524 | Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | Problems found, fixed voluntarilyMar 2023 |
| ANI Pharmaceuticals, Inc.150 mg, 225 mg, 300 mg · NDC 62559-230, 62559-231, 62559-232 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Strides Pharma Science Limited150 mg, 225 mg, 300 mg · NDC 64380-165, 64380-269, 64380-164 +3 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Propafenone 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.
- A-S Medication Solutions:
50090-2975,50090-1134,50090-4227 - American Health Packaging:
60687-709,60687-930 - Bryant Ranch Prepack:
63629-2105,71335-2780,72162-1751,72162-2616+7 - Golden State Medical Supply, Inc.:
51407-015,51407-016,51407-017 - Physicians Total Care, Inc.:
54868-4770,54868-5950 - Proficient Rx LP:
71205-940,71205-941,71205-942 - Rebel Distributors Corp..:
21695-814
Recalls
- Mar 13, 2025 · Class II · Glenmark Pharmaceuticals Inc., USA · 4 recall notices
CGMP Deviations
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.