More than 11,000 bottles of a commonly prescribed blood pressure medication are being pulled from shelves across the U.S. after failing key quality tests.
The Food and Drug Administration (FDA) announced the recall of 11,460 bottles of chlorthalidone tablets, USP, 25 mg.
Why the Medication Failed Quality Testing
FDA said the recall was issued after the tablets “failed dissolution specifications,” meaning the tablets might not break down properly in the body and could fail to deliver the intended dose.
The India-based Inventia Healthcare Limited, which manufactures the drug, started the voluntary recall on June 5.
Rising Pharma Holdings of East Brunswick, New Jersey, handles distribution of the drug in the United States.
Which Bottles and Batch Numbers Are Affected?
Bottles come in two sizes: 100 tablets and 1,000 tablets, both with an expiration date of April 2027.
For the 100-count bottles, the batch code is RISA24001 and the National Drug Code, or NDC, is 64980-599-01.
The 1,000-count bottles carry batch code RISB24002 and NDC 64980-599-10. Patients should check their medicine cabinets for these numbers on the labels.
Chlorthalidone helps the kidneys excrete excess fluid and salt from the blood into the urine, thereby lowering blood pressure.
Doctors also prescribe it to reduce swelling caused by problems with the heart, kidneys, or liver.
The recall affects many people who rely on it daily as a go-to option to manage hypertension and fluid retention.
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The problem surfaced during testing that measures how quickly and completely a tablet releases its active ingredient when placed in liquid.
Today reports that dissolution tests serve as a standard way to check drug quality and performance. When tablets fail these tests, they may not dissolve as expected inside the body.
That raises concerns about whether patients get the full benefit of the medication.
On June 22, the FDA labeled the recall as Class II, a category that covers situations where the product could cause temporary or medically reversible health effects.
It is the second time in less than a year that a widely used blood pressure treatment has been recalled.
In October 2025, the company recalled more than half a million bottles of prazosin hydrochloride because of concerns that the levels of cancer-related compounds in them were unsafe.
The pattern shows ongoing quality control challenges in the supply of common heart medications.
What Patients Should Do If They Have the Recalled Drug
Patients are now being urged to check their bottles and compare the NDC, batch number, and expiration date with the recall information.
If it matches, patients should stop taking the medicine and contact their healthcare provider.
You are also not supposed to simply throw the tablets away without guidance, as proper disposal matters for safety and the environment.
Pharmacies or doctors can often help arrange replacements or switches to another chlorthalidone formulation or a different diuretic.
The recall covers only specific lots from Inventia Healthcare Limited. Other manufacturers produce chlorthalidone, and most supplies on the market should remain unaffected.
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High blood pressure affects tens of millions of Americans. Medical experts advise that if it is left untreated, it raises the risk of heart attack, stroke, and kidney damage.
Diuretics like chlorthalidone have long played a central role because they are effective and generally well tolerated by many people.
They reduce the amount of fluid the body holds onto, easing the workload on the heart and blood vessels.
