FDA-Drug2026-01-28Class IICHEMICAL
Zydus Pharmaceuticals Icosapent Ethyl capsules recalled for reduced potency due to leakage
UNDECLARED INGREDIENTSNationwide distribution
Stop using Zydus Icosapent Ethyl capsules
Zydus Pharmaceuticals is recalling Icosapent Ethyl 1-gram capsules because some bottles may contain capsules that have lost potency (strength) due to leakage and oxidation. This means the medication may not work as intended. The recall affects specific lot numbers expiring in February and April 2027.
- Check your Icosapent Ethyl bottle for lot number S2520304, S2520333, or S2540186.
- If your bottle matches one of these lots, stop taking the medication and contact your pharmacy or doctor.
- Do not throw away the medication; return it to your pharmacy or follow local drug disposal guidelines.
- Talk to your doctor about alternatives while you wait for a replacement or new prescription.
Hazard
Subpotent Drug: Due to oxidation caused by leakage of the contents of the capsules
Sold states
US Nationwide.
Affected count
22,896 bottles
Manufactured in
73 Route 31 N, Pennington, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0295-2026More Zydus Pharmaceuticals (USA) Inc recalls
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