Blood Pressure Medication Recalled for Second Time This Year

Inventia Healthcare Limited is voluntarily recalling 13,567 bottles of Chlorthalidone Tablets, USP, 25 mg, citing concerns that the medication may not be effective. The recall, initiated due to the drug failing dissolution testing, marks the second time this year the India-based manufacturer has recalled the blood pressure medication.

This latest recall involves batch number RISA24002 with an expiration date of April 2027. Dissolution testing measures how quickly a drug dissolves in the body, a critical factor for its absorption and efficacy. When a medication fails these tests, it may not be adequately absorbed, potentially leading to reduced effectiveness.

The U.S. Food and Drug Administration (FDA) has classified this as a Class II recall. This classification indicates that the use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse health consequences is remote.

Chlorthalidone is a diuretic, commonly known as a water pill, which helps lower blood pressure by increasing the excretion of salt and water from the kidneys. Reduced efficacy in managing high blood pressure could increase the long-term risk of stroke, heart attack, kidney damage, and other complications.

Inventia Healthcare Limited previously recalled 11,460 bottles of chlorthalidone in both 100-tablet and 1,000-tablet sizes on June 5. That recall was also classified as Class II.

Patients taking the recalled medication are advised to contact their healthcare provider before discontinuing use. Abruptly stopping blood pressure medication can be dangerous, potentially leading to a rapid increase in blood pressure and an elevated risk of stroke, heart attack, kidney damage, and withdrawal symptoms.

The batch numbers associated with the recalled tablets are RISA24001, RISB24002, and RISA24002. The FDA recall numbers are D-0852-2026 and D-0610-2026.

According to the Centers for Disease Control and Prevention, over half of U.S. adults, approximately 119 million people, have high blood pressure. Hypertension is defined as a consistent reading of 130/80 mmHg or higher, and many individuals rely on medication to manage the condition. Current guidelines from the American Heart Association and the American College of Cardiology recommend prompt initiation of medication based on a patient's diagnosis and risk factors.