Reported Jan 28, 2026 · Ongoing
Icosapent Ethyl capsules, 1 gram, 120-count bottles, Rx only, Manufactured by: Softgel Healthcare Pvt. Ltd., India,…
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-count bottles, Rx only
- Manufactured bySoftgel Healthcare Pvt. Ltd., India
- Distributed byZydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1592-07
- Lot codes and dates
Lot # S2520304S2520333Exp 2/28/2027S2540186Exp 4/30/2027
- Amount recalled
- 22,896 bottles
Where it was sold
- Nationwide
Why it was recalled
Subpotent Drug: Due to oxidation caused by leakage of the contents of the capsules
This product could cause temporary or reversible health problems — stop using it.
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