Icosapent Ethyl Capsules 1 gram recall
FDA recall D-0497-2025 · initiated May 30, 2025
Zydus Pharmaceuticals (USA) Inc recalled Icosapent Ethyl Capsules 1 gram in May 2025 — an FDA Class II recall (D-0497-2025) because 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.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
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.
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: 11,616 bottles
Details
- Product
- Icosapent Ethyl Capsules 1 gram, 120 Capsules per Bottle, Rx Only, Manufactured by Doppel Farmaceutici s.r.l., Piacenza, Italy, 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
- IL, PA, & MS
- Initiated
- May 30, 2025
- FDA report date
- Jun 18, 2025
Frequently asked
- Was Icosapent Ethyl Capsules 1 gram recalled?
- Zydus Pharmaceuticals (USA) Inc recalled Icosapent Ethyl Capsules 1 gram in May 2025 — an FDA Class II recall (D-0497-2025) because 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. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Icosapent Ethyl Capsules 1 gram recalled?
- Per the FDA enforcement record, the reason for recall D-0497-2025 was: 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.
- Is a recalled Icosapent Ethyl Capsules 1 gram 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 1 gram are affected?
- Distributed: IL, PA, & MS. The recall covers these lots — Lot #s: B237040, B237041, Exp 10/31/2025. 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-0497-2025.