HIGH

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:...

Failed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidized Icosapent ethyl, the active ingredient.

Quick Facts at a Glance

Recall Date
March 9, 2026
Hazard Level
HIGH
Brands
ICOSAPENT ETHYL, Zydus Pharmaceuticals USA Inc.
Geographic Scope
1 states

Hazard Information

Failed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidized Icosapent ethyl, the active ingredient.

What You Should Do

Consumers and healthcare providers should stop using this product immediately. Contact Zydus Pharmaceuticals (USA) Inc or your healthcare provider for guidance. Notification method: Letter

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Full Description

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. Generic: ICOSAPENT ETHYL; Brand: ICOSAPENT ETHYL. Reason: Failed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidized Icosapent ethyl, the active ingredient.. Classification: Class II. Quantity: 60,541 bottles. Distribution: Nationwide in the USA

View Original Recall on FDA - Drug Safety

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Product Classification

Product Details

Model Numbers
Lot #: S2520249
S2520250
S2520267
Exp. Date 2027/Jan
S2520303
+6 more
UPC Codes
70710-1592
70710-1738
70710-1738-4
+1 more
Affected States
ALL
Report Date
March 18, 2026
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

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