ICOSAPENT ETHYL
Recalling Firm / Manufacturer: Zydus Pharmaceuticals (USA) Inc
(Pennington, NJ, United States)
FDA Recall Number: D-0400-2026
Source Authority Disclaimer: This drug recall notice is published by Questo using official enforcement reports issued by the U.S. Food & Drug Administration (FDA). It is provided for informational, academic, and clinical research purposes only. Patients should not discontinue prescribed treatments without consulting their physician or pharmacist.
Product & Identification Information
Brand, active ingredients, NDC codes, and manufacturer details
Brand / Trade Name
ICOSAPENT ETHYL
Generic Name
ICOSAPENT ETHYL
Active Substance(s)
Icosapent Ethyl
Administration Route
Oral
National Drug Code (NDC)
70710-1592
Total Quantity Recalled
60,541 bottles
Official Reason for Recall
Specific hazard or quality defect cited by the FDA
According to the official FDA enforcement report:
Failed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidized Icosapent ethyl, the active ingredient.
Full Product Description
Packaging specifications and labeling details
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
Enforcement & Regulatory Details
FDA classification, report dates, and initiation authority
Health Hazard Classification
Class II
Current Action Status
Ongoing
FDA Enforcement Report Date
March 18, 2026
Firm Initiation Date
March 09, 2026
FDA Classification Date
Mar 20, 2026
Initiation Type
Voluntary: Firm initiated
Affected Lots & Batch Numbers
Product codes, lot numbers, and expiration dates
Lot #: S2520249, S2520250, S2520267, Exp. Date 2027/Jan; S2520303, S2520305, S2520332, Exp. Date 2027/Feb; S2540208, S2540209, Exp. Date 2027/Apr
Distribution Information
Geographic scope of affected shipments
Nationwide in the USA
Safety Guidance & Actions
Standard FDA protocol for patients and healthcare providers
Patient Advisory
Check your prescription bottle or packaging against the affected lot numbers listed above. If your medication matches a recalled lot, contact your pharmacist for replacement guidance.
Healthcare Provider Guidance
Audit pharmacy stock and return affected lots to the distributor per manufacturer instructions. Notify patients where clinically indicated.
Official Source Provenance
Verified regulatory citation from U.S. FDA OpenFDA
Primary Data Source: U.S. Food & Drug Administration (FDA) OpenFDA API
Recall Number: D-0400-2026
Questo Retrieval Date: July 31, 2026 14:36 1785508606UTCC