Traces of another heart-related drug may be inside this product from a major pharmaceutical manufacturer, reveals an FDA report.
The Cleveland Clinic notes roughly 30 million Americans take beta-blocker medications for high blood pressure or anxiety. This week a newly updated recall notice from the Food and Drug Administration (FDA) suggests that those who take one particular type will want to check labels, following the discovery of “cross contamination” during manufacturing.
Glenmark Pharmaceuticals Inc., USA has initiated a nationwide recall of the combination blood pressure medication Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP after routine testing. As the FDA report reads regarding the reason for the recall, “Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe.” Ezetimibe is a cholesterol-lowering medication treating high LDL cholesterol.
The Mayo Clinic explains that Bisoprolol Fumarate and Hydrochlorothiazide work together to control blood pressure levels. Bisoprolol, a beta-blocker, works by altering nerve impulses in certain parts of the body, including the heart. “As a result, the heart beats slower and decreases the blood pressure. When the blood pressure is lowered, the amount of blood and oxygen is increased to the heart.” Meanwhile, Hydrochlorothiazide is a thiazide diuretic, also known as a water pill. “It reduces the amount of water in the body by increasing the flow of urine, which [also] helps lower the blood pressure,” Mayo experts note.
The recall, first initiated on November 21, affects 2.5-milligram/6.25-milligram (mg) strength drugs, packaged in 30-count, 100-count, and 500-count bottles. A total of 11,136 bottles of the prescription-only medication were manufactured in India and distributed nationwide across the United States. They can be identified with this information:
National Drug Codes (NDC):
- 30-Count: 68462-878-30
- 100-Count: 68462-878-01
- 5000-Count: 68462-878-05
Lot Numbers and Expiration Dates:
- Lot 17232401 — Exp. Date: 11/2025
- Lot 17240974 — Exp. Date: 05/2026
On December 1, the FDA classified the action as a Class III recall, the least severe category in a three-tier system used to communicate health risks to the public. This is used for situations “where the probability of serious adverse health consequences is remote,” the health agency says.
The classification suggests that in this case, the presence of very small quantities of ezetimibe does not pose a significant safety risk. However, taking more than the recommended dose of ezetimibe can be dangerous—and what constitutes “too much” is hard to define: “The amount of ezetimibe that can lead to overdose is different from person to person,” notes the U.K.’s National Health Services (NHS).
The incident highlights the ongoing challenges pharmaceutical manufacturers face in maintaining strict quality controls—especially when producing multiple medications within shared facilities. For patients, it serves as a reminder to check medication labels and consult providers if you suspect your prescriptions may be affected.
However, the Mayo Clinic urges against making any sudden changes to your regimen, noting that certain health conditions may become worse when the medication is discontinued. “Do not interrupt or stop taking this medicine without first checking with your doctor,” they warn.
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