Zydus Pharmaceuticals (USA) Inc recalls Icosapent Ethyl capsules
- Recalling company
- Zydus Pharmaceuticals (USA) Inc
- 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
- Subpotent Drug: Due to oxidation caused by leakage of the contents of the capsules
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Dec 30, 2025
- Reported
- Jan 28, 2026
- Distribution
- US Nationwide.
- Status
- Ongoing
- Quantity
- 22,896 bottles
- Lot / codes
- Lot # S2520304, S2520333, Exp 2/28/2027; S2540186, Exp 4/30/2027
- Company location
- Pennington, NJ
- Recall type
- Voluntary: Firm initiated
- Recall number
- D-0295-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number D-0295-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.