85%Confidence
0Views
FDASource
2026-03-31Date
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 Indian manufacturer Softgel Healthcare. This recall could impact patient trust and market share for this cardiovascular drug, especially given the visible nature of the defects that patients can easily identify.
Actionable: Monitor Zydus Pharmaceuticals' stock and consider reducing exposure until quality control improvements are confirmed.
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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