The US Food and Drug Administration (FDA) has classified a nationwide recall of chlorthalidone blood pressure tablets as Class II after more than 13,000 bottles failed dissolution testing.
Inventiva Healthcare Limited initiated the recall on September 3, while the FDA classified it as a Class II recall on September 17.
The recall involves 13,567 bottles of Chlorthalidone Tablets, USP, 25 mg, distributed across the United States.
Why was chlorthalidone recalled?
The affected tablets failed dissolution testing, which checks whether a medication breaks down and dissolves properly after it is taken.
Proper dissolution is important because a medicine generally needs to dissolve before its active ingredients can be absorbed by the body. If a tablet does not dissolve as expected, it may reduce the amount of medicine available for absorption and potentially make treatment less effective.
The recalled product carries NDC 64980-599-01 and batch number RISA24002, with an expiration date of April 2027.
According to the recall information, the affected bottles were distributed nationwide.
What does an FDA Class II recall mean?
An FDA Class II recall is used for products that may cause temporary or medically reversible adverse health consequences, while the likelihood of serious harm is considered remote.
Because chlorthalidone is used to help control high blood pressure, reduced effectiveness could potentially leave blood pressure inadequately controlled.
FDA Approves Lilly’s Mounjaro to Reduce Cardiovascular Risk in Type 2 Diabetes
Over time, poorly controlled high blood pressure can increase the risk of serious complications, including heart attack, stroke and kidney problems.
Patients taking the recalled medication should therefore check their prescription bottles and batch information to determine whether their medicine is affected.
Second chlorthalidone recall this year
The latest action is the second recall involving the same medication in 2026.
In June, Inventiva Healthcare Limited recalled 11,460 bottles of chlorthalidone tablets in 100-tablet and 1,000-tablet sizes after the products failed dissolution testing.
That earlier recall was also classified as Class II.
Patients who believe they may have an affected product should contact their pharmacist or healthcare provider for guidance rather than stopping blood pressure medication on their own.
