Icosapent Ethyl capsules recall (Zydus Pharmaceuticals (USA) Inc)
DrugClass IIOngoing
Summary: Zydus Pharmaceuticals (USA) Inc is recalling 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 to oxidation caused by leakage of the contents of the capsules.
What is being recalled
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
Why
Subpotent Drug: Due to oxidation caused by leakage of the contents of the capsules
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
US Nationwide.
How to tell if yours is affected
Lot # S2520304, S2520333, Exp 2/28/2027; S2540186, Exp 4/30/2027
What to do
Check the product name, lot number and expiration date on your package against the codes above. If they match, do not stop taking a prescription medicine without talking to your doctor or pharmacist first; ask them about a replacement. Return or dispose of the product as your pharmacy advises.
Recall facts
| Recall number | D-0295-2026 |
| Category | Drug |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | December 30, 2025 |
| Reported | January 28, 2026 |
| Company | Zydus Pharmaceuticals (USA) Inc |
| Company location | Pennington, NJ, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 22,896 bottles |
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