Zydus Pharmaceuticals USA Inc. is recalling 60,541 bottles of Icosapent Ethyl Capsules, 1 g, 120 capsules per bottle, distributed nationwide in the United States. The recall cites oxidized Icosapent Ethyl causing red dots inside capsules and melted capsules. Patients should stop using the medicine immediately and contact Zydus Pharmaceuticals USA Inc. or their clinician for guidance.
Failed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidized Icosapent ethyl, the active ingredient.
Consumers and healthcare providers should stop using this product immediately. Contact Zydus Pharmaceuticals (USA) Inc or your healthcare provider for guidance. Notification method: Letter
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Icosapent Ethyl is a prescription omega-3 fatty acid therapy used to treat high triglyceride levels. The 1 g capsule comes in a 120-count bottle and is distributed nationwide in the United States.
Oxidation of the active ingredient can produce physical changes in the capsule, including red dots and melting, which may affect safety and efficacy.
This recall is not described as part of a broader industry pattern.
Patients using this prescription therapy may need to discontinue use and seek clinician guidance. The recall could disrupt ongoing treatment for high triglycerides.
FDA recall page for D-0400-2026 and the recall notice from Zydus Pharmaceuticals USA Inc.
Refund or replacement timelines are not specified. Follow recall instructions in the notification letter.
Retain recall letters, bottle labels, NDC, lot numbers, Expiration dates, and any correspondence with the company or clinician.
Product: Icosapent Ethyl Capsules, 1 g, 120 capsules per bottle, Rx only Manufacturer: Softgel Healthcare Pvt. Ltd., India Distributor: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534 NDC: 70710-1592-7 Recall date: 2026-03-09 Quantity: 60,541 bottles Distribution: Nationwide in the United States Lot numbers/exp dates: Lot #: S2520249; S2520250; S2520267; Exp. Date 2027/Jan; S2520303; S2520305; S2520332; Exp. Date 2027/Feb; S2540208; S2540209; Exp. Date 2027/Apr
No injuries or incidents have been reported.
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