Taking care of your heart means paying attention to certain numbers, such as your blood pressure readings or cholesterol levels. But there’s another component that’s perhaps less known, but it’s one that can make a big difference when it comes to stroke or heart attack prevention.

Triglycerides—not to be confused with cholesterol—come from fats we consume via food. “Extra calories, alcohol and sugar in your body turn into triglycerides,” says the Cleveland Clinic. “Your body stores them in fat cells throughout your body like stocking shelves in a pantry.”

However, a problem arises when those levels become too high, which is a reality for about 25% of Americans, per the Cleveland Clinic. “High levels can indicate signs of other conditions, like diabetes or prediabetes, that can increase the risk of heart disease and stroke,” says the Mayo Clinic.

Now, a prescription designed to help individuals with high triglycerides is under closer scrutiny after an apparent issue was discovered.

Last week, the U.S. Food and Drug Administration (FDA) released information concerning the recall of 11,616 total bottles of Icosapent Ethyl Capsules. The medication was apparently distributed to three states: Illinois, Mississippi, and Pennsylvania.

Icosapent ethyl can be “used together with a proper diet to help control high triglyceride (fat-like substance) levels in the blood,” according to the Mayo Clinic, which also suggests the prescription medication may be combined with a statin to lower certain heart-related risks. The medication can also be referred to by the brand name Vascepa.

“Failed Tablet/Capsule specifications” is the stated reason for the recall, though additional provided information explains the unusual-sounding circumstance: “[A] product complaint was reported for burnt or melted capsules. This was determined to be a result of oxidation by leakage of capsule contents.”

Recalled product details include:

  • Icosapent Ethyl Capsules, 1 gram
  • 120 Capsules per Bottle, Rx Only
  • Lot #s: B237040, B237041
  • Expiration Date: 10/31/2025
  • Manufactured by: Doppel Farmaceutici s.r.l., Piacenza, Italy
  • Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ
  • National Drug Code (NDC): 70710-1592-7
  • Product quantity: 11,616 total bottles

The listed distributor and recalling firm, Zydus Pharmaceuticals, was also named in a digestive aid recall last month.

Interestingly, the report says the recall was first initiated on May 30, though it has not yet been classified by the FDA. The FDA typically assigns a classification to recalls to let the public know the severity of the recall event. It’s not immediately clear why the recall information just became available this week.

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Molly Jasinski
Molly Jasinski has worked as a writer, editor and social media manager for almost 15 years. She previously worked as an editor for the magazine Birds & Blooms. She’s also held other positions at Trusted Media Brands, working on direct-to-consumer books, editing special interest publications, and assisting with digital production and social me...
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Molly Jasinski