FDA-Drug2026-03-18Class IIPROCESSING DEFECT
Icosapent Ethyl Capsules, 1 gram, 120 Capsules per bottle, Rx only, Manufactured by: Softgel Healthcare Pvt. Ltd., India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. NDC: 70710-1592-7
Hazard
Failed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidized Icosapent ethyl, the active ingredient.
Intended for
Adults
Illnesses reported
None reported
Sold states
Nationwide in the USA
Affected count
60,541 bottles
Manufactured in
73 Route 31 N, N/A, Pennington, NJ, United States
Products
Icosapent Ethyl Capsules, 1 gram, 120 Capsules per bottle, Rx only, Manufactured by: Softgel Healthcare Pvt. Ltd., India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. NDC: 70710-1592-7
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0400-2026Want us to check the next one for you?
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