Recall RadarIcosapent Ethyl Capsules, 1 gram, 120 Capsules per bottle, Rx only, Manufactured by: Softgel Healthcare Pvt. Ltd., India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Penning…
Failed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidized Icosapent ethyl, the active ingredient.
Read the official FDA notice →What to do
Stop using the product and check it against the description above. Follow the remedy on the official notice; most recalls are refunded or replaced without a receipt. If you or a family member has already been affected, keep the packaging and the lot code — they're what a claim rests on later.
Details
- Recalling company
- Zydus Pharmaceuticals (USA) Inc — Pennington, NJ
- Severity
- Class II — moderate
- Reported
- March 18, 2026
- Quantity
- 60,541 bottles
- Recall number
- D-0400-2026
- Status
- Ongoing
- Source
- FDA
Where it went
Nationwide in the USA
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