A second nationwide recall of chlorthalidone blood pressure tablets from the same manufacturer has been classified by the U.S. Food and Drug Administration as a Class II recall after more than 13,000 bottles failed dissolution testing.

The latest FDA chlorthalidone dissolution testing recall involves medication that may not dissolve properly in the body, potentially preventing patients from absorbing the intended amount of the active ingredient and reducing the drug's effectiveness.

Inventia Healthcare Limited of India initiated the recall on Sept. 3, and the FDA assigned it a Class II classification on Sept. 17.

FDA Chlorthalidone Recall Covers 13,567 Bottles

The recall involves 13,567 bottles of Chlorthalidone Tablets, USP, 25 mg, distributed across the United States.

The affected product is identified by:

• NDC: 64980-599-01
• Batch No.: RISA24002
• Expiration date: April 2027

The FDA's Class II designation means using the recalled product could cause temporary or medically reversible adverse health consequences. However, the agency considers the likelihood of serious harm to be remote.

The classification nevertheless puts a spotlight on a quality-control problem that could matter greatly for patients who depend on the medication to keep their blood pressure under control.

What Failed in the Testing?

Dissolution testing measures how quickly and effectively a medication releases its active ingredient so it can become available for absorption in the body.

When a drug fails the test, the medicine may not dissolve as expected. In practical terms, a tablet can look perfectly ordinary while its performance inside the body falls short of what patients and doctors expect.

For chlorthalidone, that could mean less effective treatment.

Second Inventia Chlorthalidone Recall This Year

The latest action is not the manufacturer's first chlorthalidone recall in 2026.

In June, Inventia recalled 11,460 bottles of the same medication in 100-tablet and 1,000-tablet sizes after they failed dissolution testing for the same reason.

The FDA also classified that earlier recall as Class II.

The two recalls put thousands of bottles of chlorthalidone under scrutiny and highlight the importance of dissolution testing for medications intended to deliver consistent doses to patients.

Why Chlorthalidone Matters for Blood Pressure

Chlorthalidone is a diuretic, often referred to as a "water pill." It works by helping the kidneys remove excess water and salt from the body, which can help lower blood pressure.

For patients relying on the medication to control hypertension, reduced drug effectiveness can become more than a pharmaceutical quality issue.

Poorly controlled high blood pressure can increase the long-term risk of serious complications, including heart attack, stroke, kidney damage and other cardiovascular or kidney-related problems.

The potential concern is therefore not simply whether a tablet dissolves correctly in a laboratory. It is whether patients receive the therapeutic effect their treatment is intended to provide.

Patients Should Not Stop Medication on Their Own

Patients who believe they have the recalled chlorthalidone should not abruptly stop taking the medication without first consulting their doctor.

Stopping blood pressure medication suddenly can itself create health risks, making medical guidance especially important.

Anyone taking the medication who feels unwell or notices a change in their condition should contact a health care provider promptly.

As the FDA's second chlorthalidone recall involving Inventia this year unfolds, patients and health professionals are being urged to pay attention to the affected product details while weighing any medication changes with a medical professional.