Zydus Pharmaceuticals Icosapent Ethyl Capsules
Icosapent Ethyl Capsules have red dots inside and melted capsules due to oxidized active ingredient.
Moderate risk
Taking it may cause temporary or medically reversible health problems. Serious harm is unlikely.
FDA Class II recall · How risk is rated
What happened
Zydus Pharmaceuticals (USA) Inc., of Pennington, New Jersey, recalled Icosapent Ethyl Capsules, 1 gram, 120 Capsules per bottle, Rx only, manufactured by Softgel Healthcare Pvt. Ltd., India, because of red dots inside the capsules and melted capsules caused by oxidized Icosapent ethyl, the active ingredient. The recall began March 9, 2026, and was added to the FDA's Enforcement Report on March 12, 2026.
The product, distributed by Zydus Pharmaceuticals (USA) Inc., was distributed nationwide in the USA. The recall affected 60,541 bottles.
Summary by Recall Canary from the FDA notice.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Match the NDC and lot code listed under your product.
Icosapent Ethyl Capsules
- NDC
- 70710-1592-7
- Lot
- S2520249
- S2520250
- S2520267
- S2520303
- S2520305
- S2520332
- S2540208
- S2540209
Details
- Company began the recall
- Sold in
Nationwide in the USA
- Event ID
- 98560
- Recall No.
- D-0400-2026
- Company
- Zydus Pharmaceuticals (USA) IncPennington, New Jersey
- Hazard
- Failed specifications
- Quantity recalled
- 60,541 bottles
Company began the recall
Added to FDA's Enforcement Report
In FDA's weekly enforcement report
Classified by FDA
Listed on Recall Canary
Summary updated
