Zydus icosapent ethyl capsules recalled for subpotency
Zydus Pharmaceuticals is recalling Icosapent Ethyl 1-gram capsules because some bottles may contain capsules that have lost potency (strength) due to leakage and oxidation. This means the medication may not work as intended. The recall affects specific lot numbers expiring in February and April 2027.
From the FDA notice · Read the official notice ↗ · All Zydus recalls
What to do
- Check your Icosapent Ethyl bottle for lot number S2520304, S2520333, or S2540186.
- If your bottle matches one of these lots, stop taking the medication and contact your pharmacy or doctor.
- Do not throw away the medication; return it to your pharmacy or follow local drug disposal guidelines.
- Talk to your doctor about alternatives while you wait for a replacement or new prescription.
Is yours affected?
Compare your label or packaging with the recalled product.
- 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
- Sold in
- Nationwide
- Made for
- Adults (0 months and older)
Details
- Units affected
- 22,896 bottles
- Illnesses reported
- None reported
- Manufactured in
- 73 Route 31 N, Pennington, NJ, United States
- Classification
- Class II
- Recall number
- D-0295-2026
In the FDA's words
- Description
- 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 Subpotent Drug: Due to oxidation caused by leakage of the contents of the capsules Lot # S2520304, S2520333, Exp 2/28/2027; S2540186, Exp 4/30/2027 Distribution: US Nationwide. Affected quantity: 22,896 bottles
- Hazard
- Subpotent Drug: Due to oxidation caused by leakage of the contents of the capsules