Healthfda chlorthalidone dissolution testing recall
Summary (tl;dr)
Inventia Healthcare Limited has initiated a second nationwide recall of over 13,000 bottles of its chlorthalidone blood pressure medication due to the tablets failing dissolution testing, which means they may not dissolve properly in the body and could be less effective. This follows a similar recall in June of this year for the same reason.
Essential Background
Chlorthalidone is a diuretic, often referred to as a "water pill," prescribed to treat high blood pressure (hypertension) and fluid retention caused by conditions such as congestive heart failure, kidney disease, or liver disease. Dissolution testing is a critical quality control measure in the pharmaceutical industry to ensure that a drug dissolves correctly and releases its active ingredient at the intended rate within the body, which is essential for its efficacy. If a medication fails these tests, the active ingredient may not be absorbed properly, potentially reducing its effectiveness. Inventia Healthcare Limited had previously recalled 11,460 bottles of the same medication in June 2026 for identical dissolution issues.
The Full Story
On September 3, 2026, Inventia Healthcare Limited initiated a voluntary recall of 13,567 bottles of Chlorthalidone Tablets, USP, 25 mg, after the medication failed to meet dissolution specifications. The U.S. Food and Drug Administration (FDA) subsequently classified this as a Class II recall on September 17, 2026. A Class II recall indicates that the use of or exposure to the affected product could cause temporary or medically reversible adverse health consequences, though the probability of serious health issues is considered remote. The recalled tablets, identified by batch number RISA24002 and an expiration date of April 2027, were distributed nationwide across the United States.
Why It Matters
This recall is significant because patients rely on chlorthalidone to manage serious conditions like high blood pressure, which, if left untreated or inadequately managed, can increase the risk of heart attack, stroke, kidney damage, and other cardiovascular complications. A medication that does not dissolve properly may not deliver the intended therapeutic dose, potentially leaving patients' conditions uncontrolled. Patients currently taking this medication are advised not to discontinue it abruptly without consulting their healthcare provider, as suddenly stopping blood pressure medication can also pose health risks. They should check their medication's batch number and contact their pharmacist or doctor for guidance.
Geographic Location
- Ambernath, Maharashtra, India (manufacturing location of Inventia Healthcare Limited)
- East Brunswick, Middlesex County, New Jersey, United States (distribution location by Rising Pharma Holdings Inc.)
- United States (nationwide distribution and recall of the medication)