85%Confidence
0Views
FDASource
2026-03-29Date
Summary
Zydus Pharmaceuticals faces a Class II FDA recall for Icosapent Ethyl Capsules due to oxidation causing visible defects, indicating potential quality control issues in manufacturing. This could impact patient safety, brand reputation, and may lead to supply disruptions for this cholesterol medication.
Actionable: Monitor Zydus Pharmaceuticals for potential financial impact from recall costs and regulatory scrutiny, and assess alternative suppliers for Icosapent Ethyl.
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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