Glenmark Pharmaceuticals in New Jersey is recalling over 11,000 bottles of a blood-pressure medication, ziac, for cross-contamination concerns.
Federal regulators list the issue as low risk, but patients should check that their Ziac bottles match the affected lots.
The recalled product’s scientific names are bisoprolol fumarate and hydrochlorothiazide tablets, sold as Ziac, in 2.5 mg/6.25 mg doses.
Oversight comes from the United States Food and Drug Administration (FDA), and its recall guidance helps patients respond calmly.
Inside FDA, the Center for Drug Evaluation and Research focuses on drug safety and quality, and it works with firms on fixes.
Triggering the Ziac recall
Testing found ezetimibe, a drug that reduces cholesterol absorption in the intestine, and Glenmark began the recall.
The company first pulled product on November 21, 2025, after checking reserve samples, saved pills used to recheck a batch.
Regulators later posted it as low risk on December 1, 2025, and paperwork on the bottle remains the best way to spot it.
Cross-contamination can happen when a factory makes several drugs on shared lines and a cleaning step misses tiny residues.
Packaging errors also occur, since tablets and bottles move fast through machines that rely on correct parts and labels.
Even when trace amounts appear, quality teams treat the finding seriously because it signals a process that needs tightening.
What the medications does
Ziac treats hypertension using bisoprolol, a beta-blocker, a drug that slows heart and lowers pressure, plus hydrochlorothiazide.
Hydrochlorothiazide is a diuretic, a medicine that increases urination to reduce fluid, which can lower blood pressure.
Because it combines two drugs, prescribers watch for low potassium, dizziness, or slow pulse when doses change.
Ezetimibe is not prescribed for everyone, so even small mix-ups can surprise patients who never agreed to take it.
Most people would notice nothing, but some could face new side effects, allergy concerns, or drug interactions with other prescriptions.
Recalls also matter for trust, since patients depend on each tablet containing only what the pharmacist and prescriber expected.
What Class III means
FDA defines Class III, the lowest-risk recall category for consumers, as “not likely to cause adverse health consequences” for most users.
A Class III label does not mean no mistake happened, but it suggests serious harm is unlikely for most people.
Class I and Class II recalls sit higher on the hazard scale, so they usually trigger louder public warnings.
Ziac bottle recall numbers
Look for the NDC, a code that identifies a drug and package, on the pharmacy label or bottle. The recalled 30-count bottle uses NDC 68462-878-30, and the 100-count bottle uses NDC 68462-878-01 too.
A 500-count bottle uses NDC 68462-878-05, and the lot number, the batch identifier used to trace production, is 17232401 or 17240974.
If your code matches, call your pharmacy first, since staff can tell you whether a replacement is available quickly.
Contact the clinician who prescribes your blood-pressure medicine, and ask whether you should switch brands or keep taking it.
New symptoms should be reported to MedWatch, FDA‘s program for reporting side effects and product problems, even when risk seems low.
The Ziac label warns that stopping beta-blockers abruptly can worsen chest pain and may trigger heart attack or rhythm problems.
For many patients, clinicians taper the dose over about one week, which lowers withdrawal risk and keeps pressure stable.
A recall can also disrupt refills, so patients should request prescriptions early and avoid running out over weekends.
Why recalls feel sudden
Companies often detect problems during internal checks, then alert wholesalers and pharmacies before most patients hear anything.
Class III actions may stay mostly in supply chains, and many patients keep taking medicine unless told otherwise.
Still, a short headline can spread fast online, and it rarely explains the difference between low and high-hazard recalls.
FDA publishes weekly enforcement reports that log classified recalls, even when no public alert seems necessary.
Staff consider what could happen if the product is used, how widely it traveled, and who might take it.
A record can change as firms test samples, widen affected lots, or confirm that a limited batch caused trouble.
Quality-control pressure
Current good manufacturing practices are often shortened to cGMP in inspection reports. When plants handle many products, cGMP requires strong cleaning checks, clear paperwork, and separation that prevents mix-ups.
Those rules also push companies to keep reserve samples, track lot numbers, and prove that each step stayed under control.
A 2024 analysis reviewed 15,710 FDA recall observations from June 2012 to August 2023 and mapped the most frequent causes.
In that work, sterility was the most common issue across drug categories. The authors tied 48% of sterility recalls to assurance gaps and 45% to non-sterility, then flagged nitroso-amines, chemicals that form drug impurities.
Ziac recall takeaways
The affected bottles carry expiration dates from November 2025 through May 2026, so they may still sit in cabinets today.
Keeping a current medication list, including dose and pharmacy, makes it easier to act fast when a recall notice appears.
If you feel unwell after any medicine change, write down symptoms and timing, since details help clinicians judge cause.
This recall is labeled low risk, but it still asks patients to check codes and confirm next steps with professionals.
Recalls cannot undo a manufacturing slip, yet they can limit exposure and push companies to tighten systems under cGMP rules.
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