The U.S. Food and Drug Administration (FDA) has classified a nationwide recall of certain chlorthalidone 25 mg tabletsas a Class II recall after quality testing found the medication failed dissolution standards, raising concerns that it may not work as intended.

The recall, initiated by Inventia Healthcare Limited on September 3 and officially classified by the FDA on September 17, affects 13,567 bottles of Chlorthalidone Tablets, USP, 25 mg (NDC: 64980-599-01, Batch No. RISA24002), with an expiration date of April 2027. The products were distributed across the United States.

According to the FDA, the tablets did not pass dissolution testing, meaning they may not dissolve properly after being taken. If the medication does not dissolve as expected, the body may absorb less of the active ingredient, potentially reducing its effectiveness in controlling high blood pressure.

Chlorthalidone is a widely prescribed diuretic used to help lower blood pressure by removing excess salt and water from the body. Reduced effectiveness could leave hypertension insufficiently controlled, increasing the long-term risk of serious health complications such as heart attack, stroke, kidney disease, or other cardiovascular problems.

This marks the second nationwide recall of chlorthalidone products from Inventia Healthcare in 2026. Earlier this year, the company recalled more than 11,000 bottles of the same medication after similar dissolution testing issues. That recall was also classified by the FDA as Class II, indicating that use of the affected product could cause temporary or medically reversible health consequences, while the likelihood of serious adverse effects remains low.

Health officials advise patients not to stop taking their prescribed blood pressure medication without consulting their healthcare provider, as abruptly discontinuing treatment may pose significant health risks. Anyone who believes they may have the recalled medication or experiences changes in their condition should contact their physician or pharmacist promptly to discuss appropriate next steps.