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Zydus Pharmaceuticals (USA) Inc: Icosapent Ethyl Capsules, 1 gram, 120 Capsules per bottle, Rx only, Manufactured by: Softgel Healthcare Pvt. Ltd., India; Distributed by: Zy

DrugsSource: FDA (drug) · Date: 2026-03-18

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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 Capsules per bottle, Rx only, Manufactured by: Softgel Healthcare Pvt. Ltd., India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. NDC: 70710-1592-7
Reason / hazard
Failed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidized Icosapent ethyl, the active ingredient.
Classification
Class II
Status
Ongoing
Distribution / sold at
Nationwide in the USA
Recall initiated
2026-03-09
Code info
Lot #: S2520249, S2520250, S2520267, Exp. Date 2027/Jan; S2520303, S2520305, S2520332, Exp. Date 2027/Feb; S2540208, S2540209, Exp. Date 2027/Apr
Product quantity
60,541 bottles
Voluntary mandated
Voluntary: Firm initiated
City
Pennington
State
NJ
Country
United States
Event id
98560
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