FDAHealthMay 30, 2025
Zydus Pharmaceuticals (USA) Inc — Icosapent Ethyl Capsules 1 gram, 120 Capsules per Bottle, Rx Only, Manufactured by Doppel Farmaceutici s.r.l., Piacenza, Italy, Distributed by Zydus Pharmaceuticals (
⚠️ 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.
Is this relevant to me?
- Geography
- IL, PA, MS
- Source agency
- FDA
- Category
- Health
- Published
- May 30, 2025
IL, PA, & MS
What's affected?
- 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.
- Brand
- ICOSAPENT ETHYL
- UPC
- 0370710159276
- Lot code
- B237040
Additional details
Lot #s: B237040, B237041, Exp 10/31/2025
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 11,616 bottles.
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