United StatesIcosapent Ethyl Capsules, 1 gram, 120‑count prescription bottles (NDC 70710‑1592‑7) manufactured by Softgel Healthcare Pvt. Ltd. and distributed by Zydus Pharmaceuticals (USA) Inc. are recalled; affected lots are S2520249, S2520250, S2520267 (exp 2027/Jan); S2520303, S2520305, S2520332 (exp 2027/Feb); and S2540208, S2540209 (exp 2027/Apr). The recall was issued because capsules failed specifications, showing red dots inside and melted capsules caused by oxidized icosapent ethyl.
What's being recalled
Icosapent Ethyl Capsules, 1 gram, 120 Capsules per bottle, Rx only, Manufactured by: Softgel Healthcare Pvt. Ltd., India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. NDC: 70710-1592-7
Recalling firm: Zydus Pharmaceuticals (USA) Inc, Pennington, NJ, United States.
How to identify it
Lot #: S2520249, S2520250, S2520267, Exp. Date 2027/Jan; S2520303, S2520305, S2520332, Exp. Date 2027/Feb; S2540208, S2540209, Exp. Date 2027/Apr
The hazard
Failed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidized Icosapent ethyl, the active ingredient.
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
Nationwide in the USA
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)