United StatesIcosapent Ethyl capsules, 1 gram, 120-count prescription bottles (NDC 70710-1592-07) manufactured by Softgel Healthcare Pvt. Ltd. and distributed by Zydus Pharmaceuticals (USA) Inc., lot numbers S2520304 and S2520333 (exp. 2/28/2027) and S2540186 (exp. 4/30/2027), are being recalled nationwide in the United States. The product was recalled because it is subpotent due to oxidation caused by leakage of the capsule contents.
What's being recalled
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
Recalling firm: Zydus Pharmaceuticals (USA) Inc, Pennington, NJ, United States.
How to identify it
Lot # S2520304, S2520333, Exp 2/28/2027; S2540186, Exp 4/30/2027
The hazard
Subpotent Drug: Due to oxidation caused by leakage of the contents of the capsules
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US Nationwide.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)