More Than 25,000 Bottles of Chlorthalidone, a Blood Pressure Medication, Recalled Over Dissolution Issue

More than 25,000 bottles of a commonly used blood pressure medication have been recalled after the tablets failed dissolution specifications, raising concerns that the drug may not be absorbed properly and could be less effective.

Inventia Healthcare Limited, based in India, has issued two recalls involving chlorthalidone tablets, a medication used to help lower blood pressure. The recalls involve a combined 25,027 bottles of the drug.

The first recall, issued June 5, affected 11,460 bottles. A second recall involving 13,567 bottles was initiated Sept. 3. The U.S. Food and Drug Administration classified both recalls as Class II.

The latest recall covers Chlorthalidone Tablets, USP, 25 mg, sold in bottles containing either 100 or 1,000 tablets. The affected product has an expiration date of April 2027 and includes batch number RISA24002. The product was distributed nationwide.

Chlorthalidone is a diuretic, commonly known as a water pill. It works by helping the kidneys remove excess water and salt from the body, which can help reduce blood pressure.

The recall centers on a dissolution problem. Dissolution testing measures how quickly a medication breaks down so its active ingredient can become available for absorption. If a tablet does not dissolve as expected, there is a potential for the medication to be absorbed differently and may reduce its intended effectiveness.

The FDA's Class II designation means use of the affected product may cause temporary or medically reversible health consequences, while the probability of serious adverse health consequences is considered remote.

Patients who take chlorthalidone should check their medication bottles for the affected product and batch information. The FDA advises consumers with recalled Class II medications to generally continue taking them unless the manufacturer or FDA provides different instructions. Patients should contact their doctor or pharmacist for guidance before making changes to their medication regimen, since abruptly stopping blood pressure treatment can create health risks.

The FDA maintains a database of drug recalls and advises consumers to check the lot or batch number on their medication against the information provided in the recall notice.