Icosapent Ethyl Capsules, 1 Gram, 120-count Bottles, Rx Only, Manufactured By: Softgel Healthcare Pvt. Ltd., India, Distributed By: Zydus Pharmaceuticals (usa) Inc., Pennington, Nj 08534, Ndc 70710-15
Recall Summary Zydus Pharmaceuticals is recalling Icosapent Ethyl 1-gram capsules (120-count bottles) distributed nationwide because leakage caused the medication to oxidize and become less potent than intended. The affected medication may not work as expected and could cause increased gastrointestinal side effects in some patients. This is a serious recall affecting all U.S. states and Washington, D.C.
- Recalling firm
- Zydus Pharmaceuticals (USA) Inc
- Product
- Icosapent Ethyl capsules, 1 gram, 120-count bottles, Rx only, Manufactured by: Softgel Healthcare Pvt. Ltd., India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1592-07
- Reason
- Subpotent Drug: Due oxidation caused by leakage of the contents of the Icosapent Ethyl 1g capsules. Use of the affected product may lead to inconsistent therapeutic effects and an increase in potential gastrointestinal side effects in some patients.
- Classification
- Class I
- Category
- drug recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2025-12-30
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US Nationwide.
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/f0b4a163-f950-44df-b656-bd6f85f89d06