Icosapent Ethyl Capsules recall
FDA recall D-0400-2026 · initiated Mar 9, 2026
Zydus Pharmaceuticals (USA) Inc recalled Icosapent Ethyl Capsules in Mar 2026 — an FDA Class II recall (D-0400-2026) because Failed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidized Icosapent ethyl, the active ingredient.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Failed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidized Icosapent ethyl, the active ingredient.
The manufacturing process itself
The FDA found the process itself out of compliance, usually before any defective product was identified.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 60,541 bottles
Details
- Product
- Icosapent Ethyl Capsules, 1 gram, 120 Capsules per bottle, Rx only, Manufactured by: Softgel Healthcare Pvt. Ltd., India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. NDC: 70710-1592-7
- Recalling company
- Zydus Pharms
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA
- Initiated
- Mar 9, 2026
- FDA report date
- Mar 18, 2026
Frequently asked
- Was Icosapent Ethyl Capsules recalled?
- Zydus Pharmaceuticals (USA) Inc recalled Icosapent Ethyl Capsules in Mar 2026 — an FDA Class II recall (D-0400-2026) because Failed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidized Icosapent ethyl, the active ingredient. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Icosapent Ethyl Capsules recalled?
- Per the FDA enforcement record, the reason for recall D-0400-2026 was: Failed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidized Icosapent ethyl, the active ingredient.
- Is a recalled Icosapent Ethyl Capsules dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Icosapent Ethyl Capsules are affected?
- Distributed: Nationwide in the USA. The recall covers these lots — Lot #: S2520249, S2520250, S2520267, Exp. Date 2027/Jan; S2520303, S2520305, S2520332, Exp. Date 2027/Feb; S2540208, S2540209, Exp. Date 2027/Apr. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0400-2026.