85%Confidence
0Views
FDASource
2026-04-03Date
Summary
Zydus Pharmaceuticals faces a Class II FDA recall for Icosapent Ethyl Capsules due to oxidation causing visible defects, indicating potential quality control issues at the manufacturing partner Softgel Healthcare in India. This recall could impact patient trust in the product and may lead to supply disruptions for this prescription omega-3 medication used for cardiovascular risk reduction.
Actionable: Monitor Zydus Pharmaceuticals' stock for potential negative impact and assess alternative suppliers of icosapent ethyl products.
AI Confidence: 85%
Data Points
firmZydus Pharmaceuticals (USA) Inc
classificationClass II
statusOngoing
distributionNationwide in the USA
productIcosapent Ethyl Capsules, 1 gram, 120 Capsules per bottle, Rx only, Manufactured by: Softgel Healthcare Pvt. Ltd., India; Distributed by: Zydus Pharma
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