Is Icosapent recalled?
3 FDA recalls mention Icosapent. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Icosapent.
Class II · Moderate risk Ongoing Mar 9, 2026
Reason Failed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidized Icosapent ethyl, the active ingredient.
Class II · Moderate risk Ongoing Dec 30, 2025
Reason Subpotent Drug: Due to oxidation caused by leakage of the contents of the capsules
Class II · Moderate risk Ongoing May 30, 2025
Reason Failed Tablet/Capsule specifications; a product complaint was reported for burnt or melted capsules. This was determined to be a result of oxidation…