Icosapent Ethyl Capsules Under Class II Recall

Key Takeaways: 

• The US Food and Drug Administration (FDA) is overseeing a voluntary, firm‑initiated Class II recall of icosapent ethyl capsules, 1 g, involving 22 896 bottles distributed nationwide in the US by Zydus Pharmaceuticals (USA) Inc.
• The recall was initiated after capsule leakage led to oxidation and subpotency, which may result in inconsistent therapeutic effects and increased gastrointestinal side effects in some patients.
• Icosapent ethyl is an omega‑3 fatty acid–derived prescription therapy indicated to reduce cardiovascular risk in adults with elevated triglyceride levels, typically used as an adjunct to statin therapy.

On January 22, 2026, the US Food and Drug Administration (FDA) classified a Class II recall for Icosapent Ethyl Capsules, USP, 1 gram, due to subpotency caused by oxidation linked to leakage of capsule contents. The product, supplied in 120-count bottles (NDC 70710-1592-07), was manufactured by Softgel Healthcare Pvt. Ltd. in India and distributed by Zydus Pharmaceuticals (USA) Inc., based in Pennington, NJ. Affected bottles come from the following lots:

• S2520304, S2520333 (Exp. 2/28/2027)
• S2540186 (Exp. 4/30/2027)

The recall, involving 22 896 bottles, was voluntarily initiated by Zydus on December 30, 2025, with nationwide distribution across the United States.

The recall was prompted by reports of capsule leakage, leading to oxidation and reduced potency of the active ingredient. Subpotent doses of icosapent ethyl may result in inconsistent therapeutic efficacy and an increased risk of gastrointestinal side effects in some patients. The FDA’s Class II designation indicates that while the product may cause temporary or medically reversible adverse health effects, the likelihood of serious harm is low. 

Icosapent ethyl is an omega-3 fatty acid derivative indicated to reduce the risk of cardiovascular events in adults with elevated triglyceride levels (≥150 mg/dL) who are already on statin therapy. It is also used as an adjunct to diet in adults with severe hypertriglyceridemia. Pharmacists should review stock for the affected lot numbers, quarantine any impacted product, and coordinate with prescribers to dispense unaffected inventory or suitable alternatives. 

Reference
FDA. Enforcement Report. January 28, 2026. Accessed January 28, 2026. https://www.accessdata.fda.gov/scripts/ires/index.cfm