FDARecalled Jun 18, 2025 · #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...
Hazard
Class II — temporary health risk
Be the first to hear about future recalls.
Add the things you own to a watchlist. We’ll alert you the moment one matches.
Get started, freeDescription
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. Classification: Class II Distribution: IL, PA, & MS
Product details
- Product
- 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.
- Type
- Drugs
- Manufacturer
- Zydus Pharmaceuticals (USA) Inc
- Model numbers
- —
- UPCs
- —