FDA recall, , Moderate risk
Zydus Pharmaceuticals Icosapent Ethyl Capsules
Icosapent Ethyl capsules may be subpotent due to oxidation from leakage of capsule contents.
Summary by Recall Canary from the FDA notice
What happened
Zydus Pharmaceuticals (USA) Inc., of Pennington, New Jersey, recalled 22,896 bottles of Icosapent Ethyl capsules, 1 gram, 120-count bottles, Rx only, manufactured by Softgel Healthcare Pvt. Ltd., India, and distributed by Zydus Pharmaceuticals (USA) Inc. The agency stated the drug is subpotent due to oxidation caused by leakage of the contents of the capsules. The recall began on December 30, 2025, and was added to the FDA's Enforcement Report on January 22, 2026.
The product was distributed nationwide in the US. The recall was classified by the FDA on January 22, 2026, and in the FDA's weekly enforcement report on January 28, 2026.
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.
An NDC (National Drug Code) is usually printed on the drug's label.
Icosapent Ethyl capsules
- NDC
- 70710-1592-07
- Lot code
- S2520304
- S2520333
- S2540186
Recall details
- Company began the recall
- Sold in
US Nationwide.
- Company
- Zydus Pharmaceuticals (USA) IncPennington, New Jersey
- Hazard
- Wrong drug strength
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98227
- Recall number
- D-0295-2026
- Quantity recalled
- 22,896 bottles
All recalls from Zydus Pharmaceuticals (USA) Inc
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
