FDA Recalls Glenmark’s Ziac Blood Pressure Pills Over Contamination with Cholesterol Drug Ezetimibe

FDA Recall of Contaminated Blood Pressure Medication Raises Legal Concerns for Patients Nationwide

On December 1, 2025, the U.S. Food and Drug Administration (FDA) announced a nationwide recall of approximately 11,100 bottles of blood pressure medication manufactured by Glenmark Pharmaceuticals. The reason: the discovery of trace amounts of ezetimibe, a cholesterol-lowering drug, in reserve samples of the hypertension drug combination bisoprolol fumarate and hydrochlorothiazide, sold under the brand name Ziac.

Although the FDA classified the recall as Class III—meaning the risk of adverse health consequences is considered low, patients taking these drugs may have unknowingly been exposed to a drug they were never prescribed. Cross-contamination, even at trace levels, can pose a threat to vulnerable populations, including those with pre-existing medical conditions or those taking other cholesterol-lowering drugs.

Glenmark Pharmaceuticals, based in Elmwood Park, New Jersey, manufactures both the affected blood pressure medication and ezetimibe, increasing the likelihood that the contamination occurred during the manufacturing process.

How the Blood Pressure Medication Works and Why Contamination Matters

The combination of bisoprolol fumarate and hydrochlorothiazide is commonly prescribed to patients with high blood pressure. Each ingredient serves a specific function:

• Bisoprolol fumarate is a beta-blocker that slows the heart rate and reduces the heart’s workload.
• Hydrochlorothiazide is a diuretic (water pill) that helps remove excess fluid and sodium through urination.

Together, these medications reduce blood pressure, lower the risk of strokes and heart attacks, and are used in long-term cardiovascular health management.

However, the unintended presence of ezetimibe, a drug used to block cholesterol absorption, introduces variables that patients and their doctors didn’t anticipate. Individuals may be on specific medication regimens, and introducing ezetimibe, intentionally or not, can interfere with liver function, cholesterol metabolism, or cause drug interactions.

For people with liver disease, statin use, or sensitivity to cholesterol medications, this contamination could result in unexpected side effects, complications, or exacerbate existing health issues.

Products Included in the Recall and How to Identify Them

The FDA recall covers multiple package sizes and dosage strengths of the Glenmark-manufactured blood pressure pills. According to the agency, the affected pills are:

• 2.5 mg / 6.25 mg dose combination
• Packaged in 30-count (NDC 68462-878-30), 100-count (NDC 68462-878-01), and 500-count (NDC 68462-878-05) bottles
• With expiration dates ranging from November 2025 to May 2026

Consumers and healthcare providers should check prescription labels and packaging for matching National Drug Codes (NDCs) and lot numbers to determine if their supply is part of the recall. Patients who suspect they may have been given medication from these batches should consult their pharmacist and physician immediately.

The Dangers of Cross-Contamination in Drug Manufacturing

Cross-contamination in pharmaceutical production is not just a quality control issue—it can lead to unintended health risks for consumers. Even trace amounts of another active pharmaceutical ingredient (API) can interfere with a patient’s existing treatment plan.

In this case, the contamination involved ezetimibe, a drug not intended for blood pressure regulation. While the FDA has determined the contamination level is unlikely to cause immediate harm, the long-term effects of unintended drug ingestion are not fully understood, especially for:

• Patients already taking cholesterol medications
• Those with liver or kidney disease
• Patients on multi-drug regimens
• Elderly or immunocompromised individuals

Cross-contamination can also impact drug efficacy, meaning patients may not receive the full therapeutic benefit of their blood pressure medication, potentially putting them at increased risk for cardiac events.

Glenmark Pharmaceuticals’ Role and Previous Safety Concerns

Glenmark Pharmaceuticals is a major global manufacturer of generic medications, including cardiovascular and cholesterol treatments. The fact that both the contaminated product and the contaminating drug originated from the same manufacturer raises serious questions about quality assurance protocols at the company’s production facilities.

This is not the first time pharmaceutical companies have faced scrutiny over manufacturing lapses that affected patient safety. Historically, contamination events have led to wide-scale recalls, regulatory penalties, and in some cases, legal action by affected patients.

For Glenmark, the potential legal exposure may depend on whether the company followed FDA-mandated Good Manufacturing Practices (GMP) and whether it appropriately addressed internal cross-contamination risks during the production process.

Health Risks Patients Should Watch For

While the FDA’s classification suggests limited health risk, that does not mean zero risk. Unintended exposure to ezetimibe can lead to:

• Muscle pain or weakness (especially when combined with statins)
• Liver enzyme changes or liver stress
• Digestive issues
• Headaches or dizziness
• Unknown interactions with other prescribed drugs

If a patient has experienced new or worsening symptoms while taking the recalled medication, it is important to document those changes, consult with a healthcare provider, and preserve any remaining medication or packaging. This documentation may be critical in supporting a future legal claim.

Who May Have a Legal Claim?

People who unknowingly consumed a contaminated prescription drug and suffered harm—whether through physical side effects, financial loss, or psychological distress—may have grounds for legal action.

Potential claimants include:

• Patients who experienced adverse reactions linked to ezetimibe exposure
• Individuals hospitalized for new or unexplained symptoms while on the affected medication
• Patients whose blood pressure worsened due to interference with treatment
• Anyone who required additional medical treatment or changes in prescriptions due to the contamination

Even if the health effects were not catastrophic, the failure to provide safe, uncontaminated medication may give rise to a claim for product liability, negligence, or breach of warranty under U.S. law.

Legal Remedies Available to Affected Patients

If contamination is confirmed and harm is documented, individuals may be entitled to recover:

• Medical expenses, including doctor visits, hospitalizations, and medication changes
• Out-of-pocket costs related to replacement prescriptions
• Lost income due to missed work from illness
• Compensation for pain, suffering, and emotional distress
• Punitive damages, if the manufacturer is found to have acted with negligence or disregard for safety

Filing a product liability claim can also help hold pharmaceutical companies accountable and encourage better safety standards industry-wide.

Glenmark Blood Pressure Medication Frequently Asked Questions (FAQs)

What drug was recalled and why?

Glenmark’s bisoprolol fumarate and hydrochlorothiazide tablets (sold under the brand name Ziac) were recalled after testing found trace amounts of ezetimibe, a cholesterol-lowering drug, in certain batches. The contamination was not disclosed to patients, creating possible safety concerns.

Is this contamination dangerous?

The FDA labeled the recall as Class III, which means the health risk is considered low. However, unintended drug exposure can still cause harm, especially in sensitive populations or those on multiple medications.

What bottles are affected?

The recall involves 30-, 100-, and 500-count bottles with NDC numbers 68462-878-30, 68462-878-01, and 68462-878-05. Expiration dates range from November 2025 to May 2026.

What is ezetimibe, and why is it a problem?

Ezetimibe is a medication used to reduce cholesterol levels by limiting absorption in the intestines. It is not intended for patients on blood pressure medication unless specifically prescribed, and it can interact with other medications or cause liver-related side effects.

What should I do if I took the recalled pills?

Contact your healthcare provider and pharmacist to verify whether your prescription was from an affected lot. If you experienced symptoms or complications, keep the remaining pills and packaging for documentation.

Can I file a lawsuit for being given contaminated medication?

Yes, if you experienced harm or health complications linked to the contaminated pills, you may have a product liability or negligence claim against Glenmark Pharmaceuticals.

Contact Parker Waichman LLP For A Free Case Review

If you or someone you care about took Glenmark’s blood pressure medication and later experienced unusual side effects, unexpected health changes, or received confirmation that your prescription was from a contaminated lot, you may be entitled to compensation.

The legal team at Parker Waichman LLP, a national personal injury law firm, is reviewing claims from patients nationwide who may have been affected by this FDA-recalled medication.

Call 1-800-YOUR-LAWYER (1-800-968-7529) for a free consultation. You deserve answers. Regardless of your location or where your injury occurred, our nationwide product injury law firm is ready to assist you. Let us help you hold negligent drug manufacturers accountable and pursue the justice you may be owed.