Icosapent Ethyl Capsules, 1 gram, 120 Capsules per bottle, Rx only
Recalled by Zydus Pharmaceuticals (USA) Inc
Class II — moderate
Using this product might cause a temporary or medically reversible health problem. The chance of serious harm is low.
Zydus Pharmaceuticals (USA) Inc has recalled Icosapent Ethyl Capsules, 1 gram, 120 Capsules per bottle, Rx only, according to data published by the U.S. Food and Drug Administration (FDA). The recall was reported on March 18, 2026 and was initiated on March 9, 2026. 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 Capsules per bottle, Rx only, with approximately 60,541 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 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”
Why was Icosapent Ethyl Capsules, 1 gram, 120 Capsules per bottle, Rx only recalled?
According to the FDA, the stated reason for the recall is: “Failed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidized Icosapent ethyl, the active ingredient.”
What should you do?
If you think you may have bought Icosapent Ethyl Capsules, 1 gram, 120 Capsules per bottle, Rx only, compare it against the product description and identifying codes (Lot #: S2520249, S2520250, S2520267, Exp. Date 2027/Jan; S2520303, S2520305, S2520332, Exp. Date 2027/Feb; S2540208, S2540209, Exp. Date 2027/Apr) 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.
Full recall details
- Status
- Ongoing
- Date reported
- March 18, 2026
- Recall started
- March 9, 2026
- Distributed in
- NJ
What you can do
Check whether any product you have matches the description and codes above. If it does, stop using it and follow the instructions in the official recall notice. When in doubt, contact the company or your local health authority.
Quick answers
Why was Icosapent Ethyl Capsules, 1 gram, 120 Capsules per bottle, Rx only recalled?+
According to the FDA: Failed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidiz…
How serious is this recall?+
Class II — moderate. Using this product might cause a temporary or medically reversible health problem. The chance of serious harm is low.
What should I do if I have Icosapent Ethyl Capsules, 1 gram, 120 Capsules per bottle, Rx only?+
Compare your product against the description and identifying codes on this page. If it matches, stop using it and follow the instructions in the official recall notice — this usually means returning it for a refund or discarding it. When in doubt, contact the company or your local health authority.
Opens the U.S. Food and Drug Administration (FDA) data for this recall.
Recall number: D-0400-2026. Information last synced from the FDA on July 5, 2026.