Icosapent Ethyl Capsules, 1 Gram, 120 Capsules Per Bottle, Rx Only, Manufactured By: Softgel Healthcare Pvt. Ltd., India; Distributed By: Zydus Pharmaceuticals (usa) Inc., Pennington, Nj 08534. Ndc:
- Recalling firm
- Zydus Pharmaceuticals (USA) Inc
- Product
- Icosapent Ethyl Capsules, 1 gram, 120 Capsules per bottle, Rx only, Manufactured by: Softgel Healthcare Pvt. Ltd., India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. NDC: 70710-1592-7
- Reason
- Failed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidized Icosapent ethyl, the active ingredient.
- Classification
- Class II
- Category
- drug recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-03-09
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Nationwide in the USA
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/d09b4dd4-34d9-4cce-9a1c-f31493042cca