FDA recall D-0295-2026

Product

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

Reason for recall

Subpotent Drug: Due to oxidation caused by leakage of the contents of the capsules

Distribution

US Nationwide.

Key facts

Status

Ongoing

Initiation date

2025-12-30

Report date

2026-01-28

Voluntary/Mandated

Voluntary: Firm initiated

Location

Pennington, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0295-2026