Additional Coverage:
- FDA issues urgent recall of 11,000 bottles of medication over serious contamination risk (marketrealist.com)
FDA Issues Recall for 11,000 Bottles of Blood Pressure Medication Over Contamination
Elmwood Park, NJ – The U.S. Food and Drug Administration (FDA) has announced an urgent recall of over 11,000 bottles of blood pressure medication, Ziac, due to contamination with a cholesterol-lowering drug. While the FDA has issued a Class III warning, indicating a low likelihood of adverse health consequences, consumers are advised to exercise caution.
The recall, issued on December 1, affects combination medication bisoprolol fumarate and hydrochlorothiazide, sold under the brand name Ziac. Testing revealed trace amounts of ezetimibe, a prescription drug used to treat high cholesterol. Both the blood pressure medication and the cholesterol drug are manufactured by Glenmark Pharmaceuticals, based in Elmwood Park, New Jersey.
Affected pills come in 2.5-milligram and 6.25-milligram doses. The recall applies to 30-count bottles (NDC 68462-878-30), 100-count bottles (NDC 68462-878-01), and 500-count bottles (NDC 68462-878-05). These bottles carry expiry dates ranging from November 2025 to May 2026.
Consumers who have purchased the recalled Ziac medication are encouraged to have their pills checked out as soon as possible. As of this report, neither the FDA nor Glenmark Pharmaceuticals have provided further comment.
This recall follows an October Class II warning issued by the FDA for another medication containing “N-nitroso Prazosin impurity C,” a potentially cancer-causing chemical. That recall impacted hundreds of thousands of bottles of 1 mg, 2 mg, and 5 mg capsules.