Zydus Pharmaceuticals (USA) Inc

Drug Recalls (Class II)

Class II D-0400-2026 · 20260318 · Ongoing

Product

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. ND...

Reason for Recall

Failed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidized Icosapent ethyl, the active ingredient.

Distribution

Nationwide in the USA

Source: openFDA Enforcement API