More than 11,000 bottles of Ziac were pulled from shelves after tests found traces of a cholesterol drug.
WASHINGTON — A New Jersey pharmaceutical company has voluntarily recalled more than 11,000 bottles of a widely used blood pressure medication after testing revealed contamination with a cholesterol-lowering drug, the Food and Drug Administration announced.
Glenmark Pharmaceuticals Inc., based in Elmwood Park, initiated the recall for specific lots of Ziac, a combination medication containing bisoprolol fumarate and hydrochlorothiazide. The tablets, manufactured at the company’s facility in Pithampur, India, were distributed nationwide.
Testing of reserve samples detected traces of ezetimibe, a prescription medication used to reduce cholesterol absorption in the intestines. The contamination appears to have occurred during the manufacturing process, according to the FDA enforcement report.
The recall affects 11,136 bottles in three sizes: 30-count, 100-count and 500-count containers. The affected lots include numbers 17232401 and 17240974, with expiration dates ranging from November 2025 to May 2026.
The FDA classified the recall as Class III, its lowest-risk category, indicating the contaminated medication is unlikely to cause adverse health effects. Ezetimibe, while safe when prescribed for cholesterol management, should not be present in blood pressure medications.
Patients taking Ziac should check their prescription bottles for the affected lot numbers, which are typically printed near the expiration date. The recalled products carry NDC numbers 68462-878-30, 68462-878-01 and 68462-878-05.
Health officials recommend patients continue taking their medication unless instructed otherwise by their healthcare provider. Those with questions about whether their medication is affected should contact their pharmacist.
The company notified customers by letter, and the recall remains ongoing as the firm works to remove affected products from distribution channels.
This recall follows a series of blood pressure medication recalls in recent months. In November, Teva Pharmaceuticals recalled more than 580,000 bottles of prazosin capsules due to quality concerns.
Patients with affected bottles should contact their pharmacy for replacement medication. Those experiencing any unusual symptoms should consult their healthcare provider.