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

FDA recall notice · announced January 28, 2026 · Zydus Pharmaceuticals (usa)

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

Reason for recall

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

Notes

Distribution: US Nationwide.
Lot/code information: Lot # S2520304, S2520333, Exp 2/28/2027; S2540186, Exp 4/30/2027
Quantity: 22,896 bottles
Status: Ongoing
Products in this recall event:
- 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 70710-15 (D-0295-2026)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.