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Zydus Pharmaceuticals (USA) Inc: Icosapent Ethyl capsules, 1 gram, 120-count bottles, Rx only, Manufactured by: Softgel Healthcare Pvt. Ltd., India, Distributed by: Zydus Ph

DrugsSource: FDA (drug) · Date: 2026-01-28

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The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.

Company / brand
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 / hazard
Subpotent Drug: Due to oxidation caused by leakage of the contents of the capsules
Classification
Class II
Status
Ongoing
Distribution / sold at
US Nationwide.
Recall initiated
2025-12-30
Code info
Lot # S2520304, S2520333, Exp 2/28/2027; S2540186, Exp 4/30/2027
Product quantity
22,896 bottles
Voluntary mandated
Voluntary: Firm initiated
City
Pennington
State
NJ
Country
United States
Event id
98227
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