Zydus Pharmaceuticals (USA) Issues Icosapent Ethyl Capsules, 1 gram, 120 Capsules per bottle, Recall | FDA Drug Safety 2026

Stock photo for illustration — not the actual recalled product. Photo by Melany @ tuinfosalud.com on Unsplash

Important Recall Alert: Icosapent Ethyl Capsules Affecting 60,541 Bottles Sold Across the U.S.

If you take Icosapent Ethyl capsules, it's important to pay attention. Zydus Pharmaceuticals (USA) Inc. has issued a product recall in the United States for 60,541 bottles of Icosapent Ethyl Capsules, 1 gram, 120 Capsules per bottle (Rx only). As American shoppers know, your health and safety are top priorities, and this recall is something you need to be aware of immediately.

This affects people taking this medication all across the U.S. This recall was initiated on March 18, 2026, so here's what you need to know to protect yourself.

What's the Problem?

Nobody wants to find out their medication is defective. The reason for this recall is that the Icosapent Ethyl capsules don't meet quality standards. Specifically, red dots inside the capsule and melted capsules have been observed. The issue stems from oxidized Icosapent ethyl, which is the active ingredient in the medication. This is categorized as a Class II recall, which means that use of or exposure to the product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

This might sound alarming, but understanding the issue is the first step to resolving it safely. Zydus Pharmaceuticals (USA) Inc. is taking steps to address the problem, and you should too.

Which Products are Included in This Recall?

This recall affects specific lots of Icosapent Ethyl Capsules, 1 gram, distributed nationwide by Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. Make sure to check your bottle for the following details. This is the information U.S. consumers need to verify.

• Product: Icosapent Ethyl Capsules, 1 gram, 120 Capsules per bottle, Rx only
• Manufactured by: Softgel Healthcare Pvt. Ltd., India
• Distributed by: Zydus Pharmaceuticals (USA) Inc.
• NDC: 70710-1592-7
• Lot Numbers:
  • S2520249, S2520250, S2520267, Exp. Date 2027/Jan
  • S2520303, S2520305, S2520332, Exp. Date 2027/Feb
  • S2540208, S2540209, Exp. Date 2027/Apr

Carefully check your Icosapent Ethyl medication against these lot numbers and expiration dates. It's really important to double-check.

What You Should Do If You Have Recalled Capsules

If you have a bottle of Zydus Pharmaceuticals Icosapent Ethyl capsules that matches the lot numbers listed above, here's what you need to do:

1. Stop Taking the Medication: Immediately discontinue use of the affected Icosapent Ethyl capsules. Don't take any more capsules from the recalled lot.
2. Contact Your Healthcare Provider: Get in touch with your doctor or healthcare provider as soon as possible. Discuss alternative medications or treatment options. It’s crucial to maintain your health while addressing this recall.
3. Return the Medication: Contact your pharmacy about how to properly return the recalled medication. They will be able to advise you on the return process, or proper disposal methods.
4. Report Adverse Reactions: If you believe you've experienced any adverse effects from taking the recalled Icosapent Ethyl capsules, report it to the FDA's MedWatch program. You can find information on how to report at www.fda.gov/medwatch.

Who is Zydus Pharmaceuticals (USA) Inc.?

Zydus Pharmaceuticals (USA) Inc. is a pharmaceutical company that distributes medications across the United States. As such, events like this product recall will affect numerous customers across the U.S. It is possible you purchased this medication from major U.S. retailers or pharmacies like CVS, Walgreens, or smaller local pharmacies. While the company is headquartered in Pennington, New Jersey, the impact of this recall is nationwide.

Zydus Pharmaceuticals (USA) Inc. is working to resolve this issue and ensure the safety of their products. For American shoppers and patients, staying informed is key.

This recall was announced by the U.S. Food and Drug Administration (FDA). For the official notice and complete details, visit www.fda.gov.