FDA warns of contamination in widely used blood-pressure drug

More than 34 million Americans take blood pressure medication every day, according to the Centers for Disease Control and Prevention (CDC). So when one of these drugs gets recalled, it could easily affect you or someone close to you.

The latest drug recall involves a hypertensive medication that should motivate patients across the country to check their medicine cabinets immediately.

The brand name of the drug is Ziac, manufactured by Glenmark Pharmaceuticals Inc., a major producer of both brand-name and generic drugs.

The company initiated a voluntary recall of over 11,100 bottles of its combination blood pressure medication, bisoprolol fumarate and hydrochlorothiazide tablets.

The FDA labeled this a Class III recall, which is the lowest tier. In practical terms, that means the agency does not expect the problem to cause harm.

Blood pressure medication contaminated during production

The Ziac recall was triggered by the discovery of cross-contamination with traces of an entirely different prescription drug: ezetimibe, a medication used to treat high cholesterol.

"Driven by economic forces, pharmaceutical manufacturers of low-cost generics often have weak quality management systems and quality assurance units that lack the authority and resources to enforce CGMP compliance effectively," Senior Fellow of Economic Studies at the Brookings Institution, Marta Wosinka, wrote in an October 2025 research paper.

Related: Voluntary vs. mandatory food recalls: what you should know

The FDA has classified this as a lower-risk recall, but any contamination involving critical, life-sustaining drugs like Ziac gets a lot of attention. Patients worry about safety, and investors worry about regulatory and financial pressures.

Earlier this year, Glenmark missed its profit estimates because of weak sales in North America, Reuters reported, but in November reported a consolidated net profit of $69.4 million for the quarter ended September 30.

What consumers need to do now

If you or a family member takes bisoprolol fumarate and hydrochlorothiazide (Ziac), follow these steps in light of the recall:

• Do not stop taking Ziac, since stopping treatment suddenly can lead to a dangerous spike in blood pressure.
• Check the lot numbers:
  30-Tablet Bottles (NDC-68462-878-30) Lot 17232401 (Expiration: 11/2025) 100-Tablet Bottles (NDC-68462-878-01) Lot 17232401 (Expiration: 11/2025) 500-Tablet Bottles (NDC-68462-878-05) Lots 17232401 (Expiration: 11/2025) and 17240974 (Expiration: 05/2026)
• Contact your provider
  Contact your pharmacist immediately to see if your prescription came from an affected lot and to arrange for a replacement. Contact your prescribing physician to discuss the next steps.

A manufacturing process failure

Glenmark found the problem during routine testing of backup samples. Glenmark found small amounts of ezetimibe (the active ingredient in cholesterol-lowering drugs such as Zetia) in bottles that should have only contained the Ziac.

Ziac combines a beta-blocker with a diuretic to manage blood pressure and keep it in a healthy range. The unexpected presence of an active ingredient meant to treat another illness, even in trace amounts, signals a breakdown in the manufacturing process.

Glenmark Pharmaceuticals is frequently implicated in recalls.

The company has recalled two dozen medications because the facility in India(BHARAT) where the drugs are made has repeatedly failed to comply with U.S. manufacturing standards set by the FDA, according to an investigative report published in April 2025 by ProPublica.

"Your firm failed to perform method validation (or verification, as appropriate) of test methods to ensure they were suitable for their intended use. Your senior leadership confirmed multiple test methods used for incoming API and drug product testing of quality attributes, such as (b)(4) content, identification, and specific rotation, have not been validated, verified, or appropriately transferred," the FDA wrote in a letter addressed to Glenmark leadership in July.

An extensive list of Glenmark's recalled drugs appears on the FDA "enforcement report," which can make details about the recalls harder to find because they are technical rather than consumer-focused.

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