Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Doppel Farmaceutici S.r.l. | Cortemaggiore, Italy | Makes it, tests it, packages it and labels it | Problems found, fixed voluntarilyJun 17, 2022 · 1 inspection |
| Softgel Healthcare Private Limited | Chengalpattu, India | Makes it, tests it, packages it and labels it | Problems found, fixed voluntarilyFeb 14, 2025 · 4 inspections |
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.
Lots: Lot #: S2520249, S2520250, S2520267, Exp. Date 2027/Jan; S2520303, S2520305, S2520332, Exp. Date 2027/Feb; S2540208, S2540209, Exp. Date 2027/Apr - Dec 30, 2025 · Class II · Zydus Pharmaceuticals (USA) Inc
Subpotent Drug: Due to oxidation caused by leakage of the contents of the capsules
Lots: Lot # S2520304, S2520333, Exp 2/28/2027; S2540186, Exp 4/30/2027 - 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.
Lots: Lot #s: B237040, B237041, Exp 10/31/2025
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Icosapent: every company that makes it
- Form
- capsule, oral
- Strength
- 1 g
- Approval
- ANDA ANDA217656
- On the market since
- Aug 4, 2023
- Package NDCs
70710-1592-7- Official label
- DailyMed (National Library of Medicine), updated Jul 7, 2026
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