WASHINGTON, D.C., December 8, 2025: A New Jersey-based pharmaceutical manufacturer has voluntarily recalled more than 11,000 bottles of a high blood pressure medication after tests found potential cross-contamination with another drug, according to the U.S. Food and Drug Administration (FDA). Glenmark Pharmaceuticals Inc., based in Elmwood Park, initiated the recall of its bisoprolol fumarate and hydrochlorothiazide tablets, marketed under the brand name Ziac. The medication is commonly prescribed to treat hypertension by combining a beta blocker with a diuretic.
The FDA said laboratory testing of retained samples detected trace amounts of ezetimibe, a cholesterol-lowering medication that is not an ingredient in Ziac. The agency classified the recall as a Class III event, meaning the affected products are not likely to cause adverse health consequences. Class III recalls are typically issued when the risk to patients is minimal but product quality or labeling does not meet required standards. The FDA said it had not received reports of injuries or illnesses associated with the recalled lots. The recall covers 11,112 bottles distributed across the United States, including 30-count bottles with National Drug Code (NDC) 68462-878-30, 100-count bottles with NDC 68462-878-01, and 500-count bottles with NDC 68462-878-05.
The affected batches carry expiration dates from November 2025 through May 2026. Glenmark has notified distributors and retailers to cease distribution and arrange for the return of affected inventory. Ezetimibe, the contaminant detected in testing, is prescribed to lower cholesterol by reducing its absorption in the small intestine. The FDA stated that the trace levels found in the samples were not expected to present a health risk, but any presence of unapproved ingredients in a drug product violates federal manufacturing standards. Patients currently using Ziac are advised to continue taking their medication as prescribed until consulting their healthcare provider.
FDA classifies Glenmark recall as Class III safety event
Glenmark Pharmaceuticals said it is conducting an internal review to identify the source of the contamination. The company manufactures a wide range of generic and branded prescription drugs and supplies products globally. The FDA said the recall demonstrates the agency’s ongoing surveillance of the U.S. drug supply to ensure compliance with safety and quality regulations. The recalled product is typically used to manage high blood pressure by lowering heart rate and reducing fluid retention. High blood pressure, or hypertension, affects nearly half of U.S. adults and is a leading risk factor for heart disease and stroke, according to public health data.
While ezetimibe contamination is unlikely to alter the therapeutic effect of Ziac, federal regulators said maintaining strict production controls is essential to patient safety and product reliability. Consumers and healthcare professionals are encouraged to check product labels for the specific NDC and lot numbers to determine if their medication is affected. Any adverse reactions or quality problems associated with the recalled product can be reported to the FDA’s MedWatch Adverse Event Reporting Program. The FDA continues to monitor voluntary recalls as part of its oversight of pharmaceutical manufacturing.
Glenmark recall underlines federal commitment to quality
The agency routinely reviews post-market testing data to identify potential product inconsistencies and works with companies to ensure corrective measures are taken. It also conducts inspections, audits, and reviews of manufacturing facilities to verify adherence to current good manufacturing practices. The Glenmark recall underscores the role of ongoing quality control in safeguarding the nation’s drug supply and maintaining public confidence in the safety, integrity, and transparency of pharmaceuticals available in the United States. – By Content Syndication Services.