A major pharmaceutical manufacturer has initiated a voluntary recall of a popular blood pressure medication. Glenmark Pharmaceuticals Inc. issued the action after identifying a risk of cross-contamination in certain batches of its bisoprolol fumarate and hydrochlorothiazide tablets, marketed under the brand name Ziac. This announcement impacts thousands of bottles distributed nationwide.
The Food and Drug Administration (FDA) published the recall notice. It specifies that reserve samples of the combination pill showed trace presence of ezetimibe. Ezetimibe is a compound primarily used to treat high cholesterol. The contamination occurred during the manufacturing process.
Bisoprolol, a beta-blocker, helps regulate the heart’s rhythm. Hydrochlorothiazide is a diuretic. It helps the body shed excess water and salt. The presence of a third, unrelated active pharmaceutical ingredient raises concerns about product purity.
The company recalled over 11,100 bottles across various package sizes. Affected products include 30-count, 100-count, and 500-count bottles. The recall targets specific lot numbers. These batches feature expiration dates ranging from November 2025 through May 2026. This wide range indicates a significant period of potential distribution.
The FDA categorized this as a Class III recall. This is the least severe classification. It means that using or being exposed to the contaminated product is unlikely to cause serious or adverse health consequences for patients. Although the contamination is not immediately life-threatening, it represents a deviation from strict quality and safety standards.
Patients taking Ziac or generic equivalents should check their prescription bottles carefully. They need to confirm if their product matches the recalled lot and dose numbers. The affected doses are 2.5 mg and 6.25 mg tablets. Patients should speak with their pharmacist or prescribing doctor immediately if they possess a recalled bottle. Healthcare providers can offer guidance on next steps, including alternative prescriptions.
This incident highlights the continuous challenges of maintaining rigorous standards in pharmaceutical production. Cross-contamination often happens when different medications are handled on the same manufacturing lines. Even trace amounts of another drug violate federal safety protocols. Such incidents require immediate corrective action and transparency with the public.
For patients managing chronic conditions like hypertension, sudden medication recalls can cause confusion and anxiety. Experts recommend patients never abruptly stop taking essential blood pressure medication without consulting a health professional first. The risk of sudden hypertension spikes from stopping medication generally outweighs the low health risk posed by a Class III recall. Patient safety remains the top priority. The swiftness of the recall ensures the removal of potentially compromised batches from pharmacies.
