Medications & Supplements/Prescription Drugs

Zydus Icosapent Ethyl Capsules Recalled for Burnt or Melted Capsules

Agency Publication Date: June 12, 2025

Summary

Zydus Pharmaceuticals (USA) Inc. is recalling 11,616 bottles of Icosapent Ethyl Capsules (1 gram), a generic medication used to lower triglycerides. The recall was initiated after reports of burnt or melted capsules, which was caused by the contents leaking and reacting with oxygen. Consumers should contact their healthcare provider or pharmacist for guidance on their treatment.

Risk

Leaking capsule contents can oxidize, causing the capsules to become burnt or melted. This degradation of the product may impact the quality, safety, and effectiveness of the medication.

What You Should Do

This recall involves 1-gram Icosapent Ethyl Capsules (120 capsules per bottle) distributed by Zydus Pharmaceuticals (USA) Inc. with NDC 70710-1592-7.
Check your medication bottle for lot numbers B237040 or B237041, both with an expiration date of 10/31/2025.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Zydus Pharmaceuticals (USA) Inc. for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Icosapent Ethyl Capsules (1 gram, 120 count)

Variants: 1 gram, Capsule

Lot Numbers:

B237040 (Exp 10/31/2025)

B237041 (Exp 10/31/2025)

NDC:

70710-1592-7

Manufactured by Doppel Farmaceutici s.r.l., Piacenza, Italy.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 96964

Status: Active

Manufacturer: Zydus Pharmaceuticals (USA) Inc

Sold By: Retail Pharmacies

Manufactured In: Italy

Units Affected: 11,616 bottles

Distributed To: Illinois, Pennsylvania, Mississippi

Agency Last Updated: June 30, 2025

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall involves 1-gram Icosapent Ethyl Capsules (120 capsules per bottle) distributed by Zydus Pharmaceuticals (USA) Inc. with NDC 70710-1592-7.

Check your medication bottle for lot numbers B237040 or B237041, both with an expiration date of 10/31/2025.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Zydus Pharmaceuticals (USA) Inc. for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.