The manufacturer was involved in a large-scale recall event earlier this year, and now a new issue with a specific prescription has come to light.
More Than 6,500 Containers of a Cholesterol Medication Have Been Recalled Nationwide and in Puerto Rico
Published on Jun. 12, 2025
High cholesterol is a growing concern in America, especially as health experts estimate that only 54.5% of the U.S. adults who could benefit from a medication for cholesterol are actually taking one—that’s as many as 47 million people.
And for those already taking a prescription to keep their cholesterol levels under control, here’s a cautionary heads-up: There’s word that a commonly used option is facing a recall.
The U.S. Food and Drug Administration (FDA) announced Tuesday that an estimated 6,759 containers of Ezetimibe and Simvastatin Tablets have been recalled—both nationwide in the U.S. and in Puerto Rico. (The agency’s report lists 6,759 CON as recalled, and an FDA document suggests the “CON” abbreviation refers to “containers.”)
According to the Mayo Clinic, ezetimibe and simvastatin are used together to treat high cholesterol. Ezetimibe works to limit cholesterol absorption, while simvastatin is a statin, which blocks an enzyme in an effort to reduce the amount of cholesterol in the body. The medication may be referred to by the brand name Vytorin.
The listed recalling firm, Glenmark Pharmaceuticals Inc., USA, was involved in a recall earlier this year for four different types of cholesterol medications.
The issue prompting the new recall, according to the report, came from “Failed Impurities/Degradation Specifications.” It further states: “Out of Specification (OOS) for related substances test for Anhydro Simvastatin at the 06-month time point during long-term stability study.”
The product details include:
- Ezetimibe and Simvastatin Tablets, 10mg/40mg
- 90-count bottle, Rx only
- Lot #: 17240195
- Expiration Date: 01/31/2026
- Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No. 2, Phase-2, Pharma Zone SEZ, Madya Pradesh, India
- Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ
- National Drug Code (NDC): 68462-323-90
- Product quantity: 6,759 containers – 90 bottle pack
It’s not immediately clear from the provided information in the report if each container includes 90 bottles.
Though the recall was evidently first initiated on May 19, the FDA designated the event as a Class III recall on June 10. Class III recalls involve products that are unlikely to cause health problems but fail to comply with FDA labeling or manufacturing regulations.
For daily wellness updates, subscribe to The Healthy by Reader’s Digest newsletter and follow The Healthy on Facebook and Instagram. Keep reading:
