The FDA has issued a Class II recall for Icosapent Ethyl Capsules (1 gram, 120 count bottles) manufactured by Softgel Healthcare Pvt. Ltd. and distributed by Zydus Pharmaceuticals (USA) Inc. The reason for the recall is the presence of red dots inside the capsules and melted capsules, attributed to oxidized Icosapent ethyl, the active ingredient. This recall affects product distributed nationwide.

Compliance officers at Zydus Pharmaceuticals and its distributors must ensure all affected product is identified and removed from circulation. Healthcare providers should be aware of this recall and check their inventory for the affected product. While specific penalties are not detailed, failure to comply with recall procedures can result in FDA enforcement actions.