11,000 bottles of blood-pressure drug recalled over dissolution failure

A voluntary recall of 11,460 bottles of chlorthalidone tablets covered chlorthalidone tablets, USP, 25 mg in 100-tablet and 1,000-tablet bottles, both from batches RISA24001 and RISB24002, each marked with an April 2027 expiration date.

Inventia Healthcare Limited initiated the recall on June 5, 2026. Rising Pharma Holdings, Inc., of East Brunswick, New Jersey, distributed the product in the United States. The Food and Drug Administration classified the action as a Class II recall, meaning the product may cause temporary or medically reversible adverse health consequences.

The reason was failed dissolution specifications. The tablets may not break down properly after swallowing, which can change how much medicine the body absorbs. Dr. Vivek Bhalla, a Stanford University hypertension specialist, said a dissolution problem could mean the drug dissolves too quickly or too slowly, making it harder for patients to receive the intended dose.

Chlorthalidone is a standard diuretic used to treat high blood pressure and fluid retention. The FDA-approved labeling for Thalitone, a chlorthalidone product, identifies it as an antihypertensive and diuretic for oral use. The recall concerns uneven delivery of the active ingredient, not acute poisoning or contamination.

Roughly half of U.S. adults have hypertension, and more than 62% of people with high blood pressure rely on medication to manage it.

Drug recalls are voluntary actions a company takes to remove a defective drug from the market or warn patients and consumers about potential risk. For patients who already have the bottles at home, the immediate step is to match the lot number and expiration date on the package, contact the dispensing pharmacy if it matches the recall, and get guidance before changing any blood-pressure regimen.