Prescription drug
Where is Icosapent made?
17 companies sell it under their own name and 4 repackagers rebottle it. Their labels name 7 factories in India, China, the United States and Italy.
India 3China 2United States 1Italy 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Zydus Pharmaceuticals (USA) Inc.0.5 g, 1 g · NDC 70710-1738, 70710-1592 | Doppel Farmaceutici S.r.l.Makes it, tests it, packages it and labels it | Cortemaggiore, Italy | Problems found, fixed voluntarilyJun 2022 |
| Softgel Healthcare Private LimitedMakes it, tests it, packages it and labels it | Chengalpattu, India | Problems found, fixed voluntarilyFeb 2025 | |
| Amneal Pharmaceuticals0.5 g, 1 g · NDC 69238-2597, 69238-2598 | Strides Pharma Science LimitedMakes it, tests it and packages it | Bengaluru, India | Problems found, fixed voluntarilyMay 2026 |
| Ascent Pharmaceuticals, Inc.0.5 g, 1 g · NDC 43602-547, 43602-291 | Ascent Pharmaceuticals IncMakes it, tests it and packages it | Central Islip, NY, United States | Problems found, fixed voluntarilyAug 2024 |
| Aurobindo Pharma Limited1 g · NDC 59651-812 | Apl Healthcare LimitedMakes it and tests it | Mahabubnagar, India | No problems foundJan 2023 |
| Camber Pharmaceuticals Inc.0.5 g, 1 g · NDC 31722-298, 31722-299 | Ascent Pharmaceuticals IncMakes it, tests it and packages it | Central Islip, NY, United States | Problems found, fixed voluntarilyAug 2024 |
| Epic Pharma, LLC0.5 g, 1 g · NDC 42806-559, 42806-576, 42806-560 | Humanwell PuraCap Pharmaceuticals (Wuhan) Co., LtdMakes it | Wuhan, China | Problems found, fixed voluntarilyMar 2025 |
| Northstar Rx LLC.1 g · NDC 16714-636, 72603-129 | Ascent Pharmaceuticals IncMakes it, tests it and packages it | Central Islip, NY, United States | Problems found, fixed voluntarilyAug 2024 |
| Qilu Pharmaceutical Co., Ltd.1 g · NDC 67184-0582 | Qilu Pharmaceutical Co., Ltd.(High Tech Zone Site)Makes it and tests it | Jinan, China | Problems found, fixed voluntarilyJan 2025 |
| Softgel Healthcare Private Limited0.5 g, 1 g · NDC 35916-1738, 35916-1592 | Softgel Healthcare Private LimitedMakes it, tests it, packages it and labels it | Chengalpattu, India | Problems found, fixed voluntarilyFeb 2025 |
| Strides Pharma Science Limited0.5 g, 1 g · NDC 64380-284, 64380-285 | Strides Pharma Science LimitedMakes it, tests it and packages it | Bengaluru, India | Problems found, fixed voluntarilyMay 2026 |
| XLCare Pharmaceuticals, Inc.0.5 g, 1 g · NDC 72865-289, 72865-290 | Ascent Pharmaceuticals IncMakes it, tests it and packages it | Central Islip, NY, United States | Problems found, fixed voluntarilyAug 2024 |
| Amarin Pharma Inc. Vascepa500 mg, 1000 mg · NDC 52937-001, 52937-101, 52937-005 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Apotex Corp.1 g · NDC 60505-4033 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Dr. Reddy's Laboratories Inc.500 mg, 1000 mg · NDC 43598-267, 43598-746 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Hikma Pharmaceuticals USA Inc.0.5 g, 1 g · NDC 0054-0621, 0054-0508 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Teva Pharmaceuticals, Inc.1 g, 500 mg · NDC 0480-0127, 0480-0126 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Vitruvias Therapeutics, Inc.1 g · NDC 69680-186 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Icosapent 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.
- American Health Packaging:
60687-764 - AvKARE, Inc.:
42291-046 - Bryant Ranch Prepack:
71335-2989,71335-3148,63629-9311,71335-3072+4 - Golden State Medical Supply, Inc.:
60429-005
Recalls
- Mar 9, 2026 · Class II · Zydus Pharmaceuticals (USA) Inc
Failed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidized Icosapent ethyl, the active ingredient. - Dec 30, 2025 · Class II · Zydus Pharmaceuticals (USA) Inc
Subpotent Drug: Due to oxidation caused by leakage of the contents of the capsules - May 30, 2025 · Class II · Zydus Pharmaceuticals (USA) Inc
Failed Tablet/Capsule specifications; a product complaint was reported for burnt or melted capsules. This was determined to be a result of oxidation by leakage of capsule contents.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.