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FDA recalls blood-pressure medication after contamination found

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High blood-pressure drug recalled across U.S.

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Federal health officials have issued a nationwide recall of thousands of bottles of a widely used blood-pressure medication after tests revealed unexpected contamination with another prescription drug.

The U.S. Food and Drug Administration (FDA) announced the recall on Dec. 1, affecting about 11,100 bottles of bisoprolol fumarate and hydrochlorothiazide, a combination sold under the brand name Ziac.

Contamination discovered

Routine testing detected “trace amounts of ezetimibe,” a cholesterol-lowering medication, in reserve samples of the tablets. The FDA classified the recall as Class III — the lowest level — meaning the contamination is not expected to cause health problems.

The affected product is manufactured by Glenmark Pharmaceuticals, which also produces ezetimibe at the same New Jersey facility.

What’s being recalled

The recall includes both 2.5 mg and 6.25 mg doses of the medication.

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Impacted bottles carry the following National Drug Codes (NDC):

  • 30-count: NDC 68462-878-30
  • 100-count: NDC 68462-878-01
  • 500-count: NDC 68462-878-05

The recalled lots expire between November 2025 and May 2026, according to the FDA.

What the medication does

The bisoprolol–hydrochlorothiazide combination is commonly prescribed for high blood pressure. Bisoprolol helps regulate the heart’s rhythm, while hydrochlorothiazide lowers fluid levels by increasing urination.

Together, they relax blood vessels and reduce the risk of stroke and heart attack.

The FDA noted that exposure to small amounts of ezetimibe, the contaminating drug, is unlikely to harm patients, but the recall was issued as a precaution.

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Sources: FDA; Mayo Clinic; FOX Business.

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