Zydus recalls icosapent ethyl 1 gram capsules because they may be weaker than labeled
The capsules can leak, which causes the contents to oxidize, so the medicine may be subpotent, meaning weaker than it should be.
What to do
The notice does not give instructions. Read the official notice for details.
Note from Recalled Today: Don't stop taking a prescribed medicine before you talk to your pharmacist or doctor.
Recall details
- 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
- Hazard
- Subpotent Drug: Due to oxidation caused by leakage of the contents of the capsules
- Units
- 22,896 bottles
- Where sold
- US Nationwide.
- FDA classification
- Class II · Ongoing
- Classified by FDA
- January 22, 2026
- Recall started
- December 30, 2025
- FDA enforcement report
- January 28, 2026
- Identifiers
- Codes: Lot # S2520304, S2520333, Exp 2/28/2027; S2540186, Exp 4/30/2027
- FDA recall number: D-0295-2026
The headline, summary and steps above are written in plain English from the official notice below. Identifiers are copied exactly as the agency published them. Always check the official notice before you act.
Official notice
The notice's own wording from FDA.
- 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 for recall
- Subpotent Drug: Due to oxidation caused by leakage of the contents of the capsules
- Classification
- Class II (Ongoing)
- Distribution
- US Nationwide.
- Quantity
- 22,896 bottles
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