Overview
- Reserve-sample testing found trace amounts of the cholesterol drug ezetimibe in specific lots of Ziac (bisoprolol fumarate/hydrochlorothiazide), prompting a voluntary recall by Glenmark Pharmaceuticals.
- The recall covers 2.5 mg and 6.25 mg tablets in 30-, 100- and 500-count bottles with NDCs 68462-878-30, 68462-878-01 and 68462-878-05.
- Affected lots include 17232401 (exp. 11/2025) and 17240974 (exp. 05/2026), totaling 11,136 bottles distributed nationwide.
- The FDA classified the action as Class III, indicating use or exposure is not likely to cause adverse health consequences, and no adverse reactions have been reported to date.
- Testing was conducted at Glenmark’s facility in Madhya Pradesh, India; regulators and the company have not issued disposal instructions, and patients are advised not to stop treatment without clinical guidance.