FDA expands recall of 11,460 Chlorthalidone tablets

A nationwide recall of a widely prescribed blood pressure medication has been expanded by federal health officials, affecting thousands of patients across the United States. The U.S. Food and Drug Administration has updated the risk classification for a voluntary recall of 11,460 bottles of Chlorthalidone Tablets, USP, 25 mg, to a Class II recall, indicating the potential for temporary or medically reversible health consequences.

The recall was initiated by the manufacturer, Inventia Healthcare Limited of India, on June 5, 2026, and is being carried out by the U.S. distributor, Rising Pharma Holdings Inc. of East Brunswick, New Jersey. The affected bottles, containing either 100 or 1,000 tablets, were distributed nationwide. The specific batches involved are RISA24001 for the 100-count bottles and RISB24002 for the 1,000-count bottles, all with an expiration date of April 2027.

The recall was prompted by a manufacturing defect described as "failed dissolution specifications." This means the tablets may not dissolve properly in the body after being swallowed, potentially preventing patients from absorbing a full therapeutic dose of the medication. Chlorthalidone is a diuretic...