Zydus Pharmaceuticals (USA) Inc. has voluntarily recalled 60,541 bottles of Icosapent Ethyl Capsules (1 gram) due to the active ingredient oxidizing. This chemical reaction has caused the capsules to melt and develop red dots inside. The recall affects 120-count bottles distributed nationwide in the United States and manufactured by Softgel Healthcare Pvt. Ltd.
The oxidation of the active ingredient and subsequent melting of the capsules can lead to failed drug specifications, potentially reducing the effectiveness of the medication or resulting in the consumption of degraded ingredients. No incidents or injuries have been reported to date.
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Manufactured by: Softgel Healthcare Pvt. Ltd., India; Distributed by: Zydus Pharmaceuticals (USA) Inc.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
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Sources: FDA iRES · Raw API Response
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