Icosapent Ethyl Capsules

Zydus Pharmaceuticals (USA) Inc. has initiated a Class II recall (D-0400-2026) for 60,541 bottles of Icosapent Ethyl Capsules, 1 gram, distributed nationwide. The recall stems from quality failures, including red dots and melted capsules, caused by oxidation of the active pharmaceutical ingredient. This event underscores critical supply chain vulnerabilities and the imperative for robust quality oversight, impacting procurement and regulatory strategies for companies relying on contract manufacturing.

Zydus Pharmaceuticals (USA) Inc. has initiated a Class II nationwide recall (D-0295-2026) for 22,896 bottles of Icosapent Ethyl capsules, 1 gram, due to subpotency caused by oxidation and capsule leakage. This voluntary recall, involving product manufactured by Softgel Healthcare Pvt. Ltd. in India, necessitates immediate supply chain review for procurement and regulatory teams, highlighting critical quality control vulnerabilities in globally sourced pharmaceutical products.