FDA recalls two contaminated blood pressure medications

The U.S. Food and Drug Administration (FDA) issued a warning on December 1st regarding approximately 11,100 bottles of two types of blood pressure medications sold under the Ziac brand – bisoprolol fumarate and hydrochlorothiazide compound drugs due to potential cross-contamination issues, prompting a nationwide recall of these medications.

Testing revealed the presence of “trace amounts” of ezetimibe in reserve samples, which is a prescription medication used to treat high cholesterol levels.

According to the FDA, the affected medication doses are 2.5 milligrams and 6.25 milligrams respectively.

The FDA additionally stated that the recall includes 30-count bottles (NDC 68462-878-30), 100-count bottles (NDC 68462-878-01), and 500-count bottles (NDC 68462-878-05).

The FDA noted that the expiration dates corresponding to the recalled batches range from November 2025 to May 2026.

Furthermore, the FDA classified this recall as Class III, indicating that the use or exposure to the contaminated products is “unlikely to cause adverse health consequences.”

According to the nonprofit academic medical center, the Mayo Clinic, bisoprolol fumarate and hydrochlorothiazide are often used in combination.

Bisoprolol helps regulate heart rhythm, while hydrochlorothiazide aids in increasing urine output, thereby excreting excess sodium and water from the body. The combination of these two medications helps relax blood vessels, lower blood pressure, and reduce the risk of heart attacks and strokes.

The recalled blood pressure medications and ezetimibe are manufactured by Glenmark Pharmaceuticals, located in Elmwood Park, New Jersey.

With its headquarters in India, Glenmark Pharmaceuticals has subsidiaries in the United States and other regions, specializing in branded drugs, generics, and over-the-counter medications, making significant contributions in fields such as dermatology, respiratory health, and oncology.

(This article was based on a report from Fox Business News)