Recall of Blood Pressure Medication due to Potential Cross-Contamination

Glenmark Pharmaceuticals Inc., a global drug manufacturer with U.S. offices in Elmwood Park, New Jersey, has initiated a recall of several batches of its bisoprolol fumarate and hydrochlorothiazide tablets, sold under the brand name Ziac. The recall comes after testing revealed possible contamination with traces of another medication.

The company, headquartered in Mumbai, India, reported that reserve sample testing detected small amounts of ezetimibe, a cholesterol-lowering drug also produced by Glenmark. The recall notice was posted on December 1 by the U.S. Food and Drug Administration (FDA).

The FDA categorized this as a Class III recall, indicating that exposure to the affected product is unlikely to result in serious health issues.

Bisoprolol/hydrochlorothiazide works by blocking beta-1 receptors in the heart, helping maintain a normal heartbeat. Additionally, it promotes increased urination to remove excess sodium and water, and relaxes blood vessels to lower blood pressure, reducing the risk of heart attack and stroke.

Details of the Recall

The affected batches include tablets ranging from 2.5 mg to 6.25 mg, manufactured in Madhya Pradesh, India, for Glenmark Pharmaceuticals, Inc. in the U.S. Specific recalled products are:

• 30-tablet bottles, NDC-68462-878-30, Lot 17232401, expiring 11/2025
• 100-tablet bottles, NDC-68462-878-01, Lot 17232401, expiring 11/2025
• 500-tablet bottles, NDC-68462-878-05, Lots 17232401, exp. 11/2025 and 17240974, exp. 05/2026

There is currently no official guidance from Glenmark or the FDA on handling the recalled tablets. Health sources recommend that anyone with affected medication should verify the lot number, consult their pharmacist or prescriber, and safely dispose of the product.

Author: Jackson Miller