Glenmark Pharmaceuticals has voluntarily recalled more than 11,000 bottles of its blood pressure medication Ziac after tests found trace amounts of the cholesterol drug ezetimibe.
Ziac is a combination medication that contains bisoprolol (a beta-blocker) and hydrochlorothiazide (a diuretic) and is primarily used to treat high blood pressure in adults.
The Class III recall covers specific lots of the tablets in 30-, 100-, and 500-count bottles distributed nationwide. Affected lot numbers are 17232401 and 17240974, with expiration dates from November 2025 through May 2026.
The New Jersey-based company, which manufactures the tablets in Pithampur, India, detected the contamination in reserve samples. The FDA said the mix-up occurred during production.
A Class III designation means that use of the product is unlikely to cause adverse health consequences.
Patients are advised to check their bottles for NDC numbers 68462-878-30, 68462-878-01, or 68462-878-05 and the listed lot numbers. They should contact their pharmacy for replacement medication.
Glenmark is removing the affected lots from the market and notifying customers by letter.