Icosapent Ethyl capsules, 1 gram, 120-count bottles, Rx only

Zydus Pharmaceuticals (USA) Inc has recalled Icosapent Ethyl capsules, 1 gram, 120-count bottles, Rx only, according to data published by the U.S. Food and Drug Administration (FDA). The recall was reported on January 28, 2026 and was initiated on December 30, 2025. It is classified as a Class II recall, which means using this product might cause a temporary or medically reversible health problem. The chance of serious harm is low.

Below is a plain-English summary of what was recalled, why it was recalled, how to tell whether you have the affected product, and what steps you can take. For the complete and most current details, you can view the FDA record linked further down this page.

What was recalled?

This recall covers Icosapent Ethyl capsules, 1 gram, 120-count bottles, Rx only, with approximately 22,896 bottles affected. The company behind the recall is Zydus Pharmaceuticals (USA) Inc, based in Pennington, NJ. The FDA describes the product as: “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”

Why was Icosapent Ethyl capsules, 1 gram, 120-count bottles, Rx only recalled?

According to the FDA, the stated reason for the recall is: “Subpotent Drug: Due to oxidation caused by leakage of the contents of the capsules.” In plain terms, this recall relates to a potency or effectiveness issue.

This recall means the medicine may be stronger or weaker than its label says, or may not release its ingredient the way it should. That matters because too little medicine may not treat the condition, and too much can cause side effects. Anyone taking an affected product is generally advised to consult their pharmacist or doctor about a replacement.

What should you do?

If you think you may have bought Icosapent Ethyl capsules, 1 gram, 120-count bottles, Rx only, compare it against the product description and identifying codes (Lot # S2520304, S2520333, Exp 2/28/2027; S2540186, Exp 4/30/2027) before using it. This recall is currently listed as ongoing.

The general guidance for a matching product is to stop using it and follow the instructions in the official FDA recall notice, which may include a repair, replacement, refund, or safe disposal. When in doubt, contact Zydus Pharmaceuticals (USA) Inc or your local health authority.

About this recall

This recall was distributed in NJ. RecallRadar summarizes recall information from public FDA data to make it easier to understand. We are an independent service and are not affiliated with the FDA or any government agency, so please always refer to the official source for the authoritative record — and note the “last synced” date shown on this page, since recall details can change over time.