FDA Announces Nationwide Recall on More Than 60,000 Bottles of a Heart-Related Drug

Before you stop taking a prescription for any reason, it’s important to speak with your doctor or pharmacist. For patients “nationwide in the USA,” the U.S. Food and Drug Administration (FDA) is suggesting that conversation may be called for.

This weekend, the agency posted a recall on what they say are 60,541 bottles of Icosapent Ethyl Capsules, containing 120 capsules each. The distributor of the recalled Icosapent Ethyl is Zydus Pharmaceuticals (USA) in Pennington, NJ. The recall’s been executed due to “Failed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidized Icosapent ethyl, the active ingredient,” as stated in the FDA report.

Here’s how this may be interpreted: Kaiser Permanente explains that icosapent ethyl is a form of omega-3 fatty acid. The FDA report suggests the ingredient underwent chemical changes, possibly due to environmental conditions (such as heat or light, suggested by the documented melting effect) during the production, storage, or shipping processes. (It appears the product was manufactured by a company called Softgel Healthcare Pvt. Ltd. in India.)

Because the active ingredient has been chemically altered, the capsules may no longer deliver the intended dose or therapeutic effect; and it’s unknown whether ingestion could cause harm.

If you take Icosapent Ethyl distributed by Zydus Pharmaceuticals, the FDA suggests the following details can help you identify affected product:

• Lots S2520249, S2520250, S2520267 – Expiration Date 2027/Jan
• Lots S2520303, S2520305, S2520332 – Expiration Date 2027/Feb
• Lots S2540208, S2540209 – Expiration Date 2027/Apr

The Mayo Clinic explains more about Icosapent Ethyl and its indications:

Icosapent ethyl is used together with a proper diet to help control high triglyceride (fat-like substance) levels in the blood. This medicine is also used together with a statin medicine to lower the risk of heart attack, stroke, and certain heart problems requiring hospitalization in adults with heart or blood vessel disease or diabetes.

Get recall news regularly from The Healthy newsletter and follow The Healthy on Facebook and Instagram. Keep reading:

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