Reported Mar 18, 2026 · Ongoing
Icosapent Ethyl Capsules, 1 gram, 120 Capsules per bottle, Rx only, Manufactured by: Softgel Healthcare Pvt. Ltd.,…
Zydus Pharmaceuticals (USA) Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Zydus Pharmaceuticals (USA) Inc · 73 Route 31 N · Pennington, NJ · 08534-3601
Is this the product you have?
- Icosapent Ethyl Capsules, 1 gram, 120 Capsules per bottle, Rx only
- Manufactured bySoftgel Healthcare Pvt. Ltd., India
- Distributed byZydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534
- NDC70710-1592-7
- Lot codes and dates
Lot #: S2520249S2520250S2520267Exp. Date 2027/JanS2520303S2520305S2520332Exp. Date 2027/FebS2540208S2540209Exp. Date 2027/Apr
- Amount recalled
- 60,541 bottles
Where it was sold
- Nationwide
Why it was recalled
Failed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidized Icosapent ethyl, the active ingredient.
This product could cause temporary or reversible health problems — stop using it.
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