Recalls / Class II

Class IID-0295-2026

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

Affected lot / code info

Lot # S2520304, S2520333, Exp 2/28/2027; S2540186, Exp 4/30/2027

Why it was recalled

Subpotent Drug: Due oxidation caused by leakage of the contents of the Icosapent Ethyl 1g capsules. Use of the affected product may lead to inconsistent therapeutic effects and an increase in potential gastrointestinal side effects in some patients.

Recalling firm

Firm

Zydus Pharmaceuticals (USA) Inc

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

73 Route 31 N, Pennington, New Jersey 08534-3601

Distribution

Quantity

22,896 bottles

Distribution pattern

US Nationwide.

Timeline

Recall initiated

2025-12-30

FDA classified

2026-01-22

Posted by FDA

2026-01-28

Status

Ongoing

Source: openFDA Drug Enforcement endpoint. Recall record D-0295-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.