FDA recall D-0497-2025

Zydus Pharmaceuticals (USA) Inc · Class II · drug

Product

Icosapent Ethyl Capsules 1 gram, 120 Capsules per Bottle, Rx Only, Manufactured by Doppel Farmaceutici s.r.l., Piacenza, Italy, Distributed by Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1592-7.

Reason for recall

Failed Tablet/Capsule specifications; a product complaint was reported for burnt or melted capsules. This was determined to be a result of oxidation by leakage of capsule contents.

Distribution

IL, PA, & MS

Key facts

Status
Ongoing
Initiation date
2025-05-30
Report date
2025-06-18
Voluntary/Mandated
Voluntary: Firm initiated
Location
Pennington, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0497-2025