Class II · Moderate risk
Icosapent Ethyl Capsules
Failed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidized Icosapent ethyl, the active ingredient.
Is Icosapent Ethyl recalled?
Yes — there is an active recall. 2 ongoing FDA recalls mention Icosapent Ethyl (3 total). Check the affected lots below.
Most common reason: Failed specification (2 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Icosapent Ethyl. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Icosapent Ethyl recalls in 2026
1 initiated in 2026, 3 in total — newest first
Class II · Moderate risk
Icosapent Ethyl capsules
Subpotent Drug: Due to oxidation caused by leakage of the contents of the capsules
Class II · Moderate risk
Icosapent Ethyl Capsules 1 gram
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.
Free recall alerts
Know the day your medication is recalled
Tell us what you take. When FDA posts a recall announcement or classifies a recall for one of your medications, we email you in plain English, with what to check. No account needed.