Thousands of Bottles of Blood Pressure Drugs Recalled Due to Cross-Contamination

The medication, which combines bisoprolol fumarate and hydrochlorothiazide, was recalled nationwide, according to the FDA.

Medications are stored on shelves at a pharmacy in Los Angeles on May 12, 2025. Eric Thayer/Getty Images

Thousands of units of a prescription medication used to treat high blood pressure were recently recalled and classified by the Food and Drug Administration (FDA) because of contamination, according to a notice issued by the agency on Dec. 1.

In a report published on Dec. 1 on the FDA’s website, more than 11,100 bottles of bisoprolol fumarate and hydrochlorothiazide tablets, USP, were recalled.

The reason for the recall is “cross contamination with other products” after “testing of reserve samples showed presence of traces of ezetimibe,” the FDA notice said. Ezetimibe is a prescription drug used to lower high blood cholesterol.

Bisoprolol fumarate, a beta blocker that slows the heart rate by relaxing blood vessels, is combined with hydrochlorothiazide, a diuretic, to more effectively treat high blood pressure than bisoprolol alone. Ezetimibe is a cholesterol absorption inhibitor.

According to the FDA notice, the recalled bisoprolol fumarate and hydrochlorothiazide tablets are in 2.5-milligram/6.25-milligram strength doses in 30-count bottles with the code NDC-68462-878-30; in 100-count bottles with the code NDC-68462-878-01; or in 500-count bottles with the code NDC-68462-878-05.

They are from lot 17232401 with an expiration date of November 2025 as well as lot 17232401 with an expiration date of May 2026, according to the notice.

The drug was manufactured by Glenmark Pharmaceuticals Limited, located in Pithampur, Madhya Pradesh, India, the notice said. It was manufactured for Glenmark Pharmaceuticals, Inc., based in Mahwah, New Jersey.

The FDA labeled the recall as Class III, which the agency defines as a product that is not likely to “cause adverse health consequences” but may violate labeling or manufacturing regulations. Class III is considered the least severe on a three-tiered scale that goes up to Class I.

Glenmark voluntarily initiated the recall on Nov. 21, and the FDA classified the recall and posted the notice on Dec. 1. The recall is ongoing and nationwide, according to the FDA.

The FDA issued a warning letter to Glenmark earlier this year regarding the same Indian factory where the recalled drugs were manufactured because its “methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform” to the FDA’s standards.

“Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed,” the warning letter stated, although it did not name any specific drugs that were manufactured at the factory.

So far in 2025, tens of thousands of units of blood pressure, cholesterol, or heart medications have been recalled across the United States. In a significant instance, Teva Pharmaceuticals USA and drug distributor Amerisource Health Services in October recalled about 500,000 bottles of prazosin hydrochloride capsules because it contained a potentially cancer-causing chemical.

Weeks before, the FDA posted a notice of recall of at least 140,000 bottles of the generic version of atorvastatin, a commonly used drug prescribed to treat cholesterol and heart issues. In August, about 88,000 bottles of carvedilol, also used to treat high blood pressure, were recalled because of the presence of potentially carcinogenic chemicals.

CORRECTION: A previous version of this article incorrectly identified the combination medication bisoprolol fumarate and hydrochlorothiazide. The Epoch Times regrets the error.