FDA-Drug2026-01-28Class II
Icosapent Ethyl capsules, 1 gram, 120-count bottles, Rx only, Manufactured by: Softgel Healthcare Pvt. Ltd., India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1592-07
Zydus Pharmaceuticals (USA) Inc
Hazard
Subpotent Drug: Due to oxidation caused by leakage of the contents of the capsules
Sold states
US Nationwide.
Affected count
22,896 bottles
Manufactured in
73 Route 31 N, Pennington, NJ, United States
Products
Icosapent Ethyl capsules, 1 gram, 120-count bottles, Rx only, Manufactured by: Softgel Healthcare Pvt. Ltd., India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1592-07
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0295-2026Don't want to check this manually?
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