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Icosapent Ethyl Capsules, 1 gram
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DRUG RECALLMODERATE

Icosapent Ethyl Capsules, 1 gram

Zydus Pharmaceuticals is recalling Icosapent Ethyl Capsules (NDC 70710-1592-7) due to oxidized ingredient causing red dots and melted capsules.

What to do

Stop taking this medication and contact your pharmacy or healthcare provider immediately for a replacement or alternative treatment. Do not use capsules with red dots or visible melting.

Posted
Updated
Recall No.
D-0400-2026
Agency
Firm
Zydus Pharmaceuticals (USA) Inc
Recall ID
98560
Status
ONGOING

Why it was recalled

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

How to identify it

Icosapent Ethyl Capsules, 1 gram, 120 Capsules per bottle, Rx only, Manufactured by: Softgel Healthcare Pvt. Ltd., India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. NDC: 70710-1592-7

Where it was sold

Distributed in US.

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Editorial summary by Recall Canary · last updated 2026-04-27 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification