Glenmark Pharmaceuticals, the company behind the product, found that the tablets, which combine bisoprolol fumarate and hydrochlorothiazide, were cross-contaminated with ezetimibe, a medication used to lower cholesterol. While the contamination is unlikely to pose significant health risks, the recall raises important questions about drug safety and oversight.
What’s in the Recall?
According to the FDA, the recall involves several lots of Ziac tablets, sold in 30-, 100-, and 500-count bottles. The affected medications, manufactured by Glenmark Pharmaceuticals in India and distributed in the U.S. under the brand name Ziac, are prescribed for hypertension and help lower blood pressure while reducing the risk of heart attacks and strokes. The recall was triggered after reserve samples of the drug showed traces of ezetimibe, a cholesterol-lowering drug also produced by Glenmark. The affected lots include:
- 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), Lot 17232401, exp. 11/2025 and Lot 17240974, exp. 05/2026
The recall has been classified as a Class III issue by the FDA, meaning that the contamination is not likely to cause harm to patients who have been exposed to the drugs. Despite this, the FDA has advised patients to stop using the affected medications and consult their pharmacist.
Why This Matters
While the trace contamination of a cholesterol drug in a blood pressure medication may seem minimal, it underscores the complexities of pharmaceutical manufacturing. Glenmark Pharmaceuticals, based in Elmwood Park, New Jersey, noted that the contamination occurred due to cross-contact between the two drugs during the production process. This kind of cross-contamination, even at small levels, can raise concerns about the consistency and safety of pharmaceuticals, particularly when drugs are manufactured in bulk for global markets.
Hypertension, or high blood pressure, affects millions of people worldwide, making medications like Ziac essential for managing this widespread condition. Bisoprolol fumarate and hydrochlorothiazide, the two active ingredients in Ziac, are commonly prescribed together to lower blood pressure, improve heart function, and reduce the risk of heart attacks and strokes. For those using Ziac, it’s important to verify whether they have the affected lots, as the recall could impact ongoing treatment plans.
Glenmark Pharmaceuticals has yet to provide specific instructions on how to dispose of the recalled medications. However, the FDA advises patients to check the lot numbers on their bottles and consult their pharmacist for advice on what steps to take next. Affected patients are also urged to speak with their healthcare providers to determine an alternative course of treatment.
This recall highlights ongoing concerns about quality control in the pharmaceutical industry, particularly as more drug production is outsourced to overseas facilities. Glenmark’s manufacturing plant in India has faced scrutiny in the past for compliance issues, making this recall a reminder of the importance of rigorous oversight in the drug production process.
The FDA’s response, although limited to a Class III classification, shows that even minor manufacturing errors can lead to widespread recalls. It’s a reminder that cross-contamination can have serious implications, especially for people relying on medications to manage chronic conditions.
