FDA Recall D-0497-2025

Zydus Pharmaceuticals (USA) Inc · Pennington, NJ

Class II Ongoing 349 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

Product

Icosapent Ethyl Capsules 1 gram, 120 Capsules per Bottle, Rx Only, Manufactured by Doppel Farmaceutici s.r.l., Piacenza, Italy, Distributed by Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1592-7.

Lot / code: Lot #s: B237040, B237041, Exp 10/31/2025

Quantity: 11,616 bottles

Reason for recall

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.

Recall record

Recall number: D-0497-2025
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: IL, PA, & MS
Recall initiated: 2025-05-30
Classified by FDA Center: 2025-06-30
FDA published: 2025-06-18
Recalling firm: Zydus Pharmaceuticals (USA) Inc
Firm location: Pennington, NJ

Drug identification

Brand name(s): ICOSAPENT ETHYL
Generic name(s): ICOSAPENT ETHYL
Manufacturer(s): Zydus Pharmaceuticals USA Inc.
NDC(s): 70710-1592, 70710-1738
Route(s): ORAL

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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