Icosapent Ethyl capsules recall
FDA recall D-0295-2026 · initiated Dec 30, 2025
Zydus Pharmaceuticals (USA) Inc recalled Icosapent Ethyl capsules in Dec 2025 — an FDA Class II recall (D-0295-2026) because Subpotent Drug: Due to oxidation caused by leakage of the contents of the capsules.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Subpotent Drug: Due to oxidation caused by leakage of the contents of the capsules
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
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: 22,896 bottles
Details
- Product
- Icosapent Ethyl capsules, 1 gram, 120-count bottles, Rx only, Manufactured by: Softgel Healthcare Pvt. Ltd., India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1592-07
- Recalling company
- Zydus Pharms
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- US Nationwide.
- Initiated
- Dec 30, 2025
- FDA report date
- Jan 28, 2026
Frequently asked
- Was Icosapent Ethyl capsules recalled?
- Zydus Pharmaceuticals (USA) Inc recalled Icosapent Ethyl capsules in Dec 2025 — an FDA Class II recall (D-0295-2026) because Subpotent Drug: Due to oxidation caused by leakage of the contents of the capsules. 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-0295-2026 was: Subpotent Drug: Due to oxidation caused by leakage of the contents of the capsules
- 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: US Nationwide.. The recall covers these lots — Lot # S2520304, S2520333, Exp 2/28/2027; S2540186, Exp 4/30/2027. 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-0295-2026.