Reported Jun 18, 2025 · Ongoing
Icosapent Ethyl Capsules 1 gram, 120 Capsules per Bottle, Rx Only, Manufactured by Doppel Farmaceutici s.r.l.,…
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 by Doppel Farmaceutici s.r.l., Piacenza, Italy, Distributed by Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1592-7.
- Lot codes and dates
Lot #s: B237040B237041Exp 10/31/2025
- Amount recalled
- 11,616 bottles
Where it was sold
Why it was recalled
Failed Tablet/Capsule specifications; a product complaint was reported for burnt or melted capsules. This was determined to be a result of oxidation by leakage of capsule contents.
This product could cause temporary or reversible health problems — stop using it.
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