Heart disease has been the leading cause of death in the U.S. for more than 100 years, yet more than half of American adults don’t know that, according to a 2024 report from the American Heart Association (AHA). The findings were described as “discouraging and even a bit frightening” by immediate-past president for the AHA, Joseph C. Wu, MD, PhD, FAHA.
Dr. Wu also noted that the general lack of knowledge surrounded heart disease’s impact could be “potentially deadly,” stating in part that high blood pressure “is a leading risk factor for heart disease and stroke, and yet with proper treatment and management it can be controlled and your risk for cardiovascular disease can be greatly reduced.”
So if you rely on a prescription to lower your blood pressure, there’s a new recall to know about. In a report released publicly by the U.S. Food and Drug Administration (FDA) on August 9, New Jersey-based Ascend Laboratories, LLC, is recalling a total of 8,568 bottles of Amlodipine and Olmesartan Medoxomil tablets (5 milligram/40 milligram). The recall is further described as “ongoing” with distribution “nationwide in the USA.”
Offered under the brand name Azor, the combination of amlodipine and olmesartan work together to treat high blood pressure, according to the Mayo Clinic. Amlodipine is a calcium channel blocker (CCB) while olmesartan is an angiotensin II receptor blocker (ARB). Both work to help blood vessels relax, per Mayo, which in turn “increases the supply of blood and oxygen to the heart.”
The FDA’s report explains the recall reason as “Failed Dissolution Specifications: low dissolution results,” potentially meaning the medication did not break down at the recommended rate. A drug’s ability to dissolve is important “for its bioavailability and therapeutic effectiveness,” says the U.S. Pharmacopeia, a 200-year-old nonprofit organization that helps set quality standards for medicines, food, and dietary supplements.
The following product details were provided:
- Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/40 mg
- 30-count bottle
- Rx Only
- Lot Code: 23121560
- Expiration Date: 4/30/2026
- Manufactured by: Alkem Laboratories Ltd., INDIA
- Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054
- National Drug Code (NDC): 67877-501-30
According to the Ascend Laboratories website, the company is “a wholly owned subsidiary of Alkem.”
Though this recall was initiated on July 21, the FDA didn’t designate it as a Class II event until August 8. As a Class II, the recall is identified as “a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
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