Icosapent Ethyl capsules recall: Subpotent
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 was Icosapent Ethyl capsules recalled?
Subpotent Drug: Due to oxidation caused by leakage of the contents of the capsules
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot # S2520304, S2520333, Exp 2/28/2027; S2540186, Exp 4/30/2027
- 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
- Recalling firm
- Zydus Pharmaceuticals (USA) Inc
- Quantity
- 22,896 bottles
- Distribution
- US Nationwide.
- Recall date
- January 28, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)