FDAFDA · Food and drugs·Recall number D-0497-2025
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.
Published June 18, 2025 · Recall initiated: May 30, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- ICOSAPENT ETHYL
- Manufacturer
- Zydus Pharmaceuticals (USA) Inc
- Distributor
- IL, PA, & MS
- UPC
- 0370710159276
- Lot
- Lot #s: B237040, B237041, Exp 10/31/2025
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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