Thousands of bottles of a commonly used prescription drug to treat hypertension has been recalled for possible contamination with another drug.
Glenmark Pharmaceuticals Inc., which has U.S. headquarters in Elmwood Park, New Jersey, has recalled multiple lots of bisoprolol fumarate and hydrochlorothiazide tablets (brand name Ziac), because the tablets may have been cross contaminated with other products, according to a recall report published online by the Food and Drug Administration.
The global drug maker, which is headquartered in Mumbai, India, said testing of reserve samples showed presence of traces of ezetimibe, a cholesterol drug the company also produces, according to the recall, posted this week.
The FDA classified the recall with a Class III risk level, which suggests “use of or exposure to a violative product is not likely to cause adverse health consequences,” according to the agency.
Bisoprolol/hydrochlorothiazide blocks beta-1 receptors in your heart, allowing the heart to beat normally, according to WebMD. The drug also increases urination to remove sodium and water from the body, as well as relaxes blood vessels – to help lower blood pressure and help to reduce heart attack and stroke risk.
What blood pressure medicine is being recalled?
The recall involves an undeclared number of lots of tablets, from 2.5 mg to 6.25 mg dosages, in various sized bottles, manufactured in Madhya Pradesh, India for Glenmark Pharmaceuticals, Inc., USA.
These lots were recalled:
- 30-tablet bottles, NDC-68462-878-30. Lot 17232401, exp. 11/2025.
- 100-tablet bottles, NDC-68462-878-01. Lot 17232401, exp. 11/2025.
- 500-tablet bottles, NDC-68462-878-05. Lots 17232401, exp. 11/2025 and 17240974, exp. 05/2026.
The press has reached out to Glenmark Pharmaceuticals. Neither Glenmark nor the FDA have issued guidance on what to do with the recalled tablets.
But according to GoodRx, anyone affected by a drug recall is advised to check their medication’s lot number, contact their pharmacist as well as their prescriber and throw away the recalled medication.
