Official recall notice
FDA DrugClass IINotable
FDA Recall: Icosapent Ethyl Capsules, 1 gram, 120 Capsules per bottle, Rx only, Manufactured by: Softgel Healthc
- Recall date
- 2026-03-18
- Category
- Drug
- FDA class
- Class II
Why it was recalled
Hazard
Failed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidized Icosapent ethyl, the active ingredient.
Recommended action
What to do
60,541 bottles
Product description
Failed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidized Icosapent ethyl, the active ingredient.