Drugplain

Icosapent ethyl 1 g/1

Icosapent ethyl · CAPSULE · Strides Pharma Science Limited

3 Recalls on Record
Plain English

Icosapent ethyl is a capsule containing icosapent ethyl at 1 g/1, taken oral. Manufactured by Strides Pharma Science Limited.

Key Facts

Brand Name
Icosapent ethyl
Generic Name
Icosapent ethyl
NDC Code (Product)
64380-285
Manufacturer
Strides Pharma Science Limited
Strength
1 g/1
Dosage Form
CAPSULE
Route
ORAL
Marketing Status
Application #
ANDA217844
Marketing Start
05/22/2026

Recall History

3 Recalls on Record
Class II05/30/2025

Zydus Pharmaceuticals (USA) Inc

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.

OngoingVoluntary: Firm initiated
Class II12/30/2025

Zydus Pharmaceuticals (USA) Inc

Subpotent Drug: Due to oxidation caused by leakage of the contents of the capsules

OngoingVoluntary: Firm initiated
Class II03/09/2026

Zydus Pharmaceuticals (USA) Inc

Failed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidized Icosapent ethyl, the active ingredient.

OngoingVoluntary: Firm initiated

Frequently Asked Questions

What is Icosapent ethyl used for?

Icosapent ethyl contains Icosapent ethyl. It is a capsule taken oral. Consult your doctor for specific uses.

Is Icosapent ethyl a controlled substance?

Icosapent ethyl is not classified as a controlled substance by the DEA.

What is the generic name for Icosapent ethyl?

The generic name for Icosapent ethyl is Icosapent ethyl. There are 11 other brand versions of Icosapent ethyl.

What is the NDC code for Icosapent ethyl 1 g/1?

The NDC (National Drug Code) for Icosapent ethyl 1 g/1 is 64380-285, listed by Strides Pharma Science Limited.