Urgent FDA Recall: Chlorthalidone Tablets Pulled Nationwide After Dissolution Test Failure—Check Affected Lots Now

The U.S. Food and Drug Administration (FDA) has announced a nationwide voluntary recall of 11,460 bottles of chlorthalidone tablets, USP 25 mg, after routine dissolution testing showed the medication may not dissolve properly and could therefore deliver sub-therapeutic doses. Inventia Healthcare Ltd. of Mumbai manufactured the affected lots—RISA24001 (100-count) and RISB24002 (1,000-count)—which carry an expiration date of 04/2027 and were distributed in the United States by Rising Pharma Holdings, Inc. Why dissolution matters • Dissolution testing simulates how quickly a pill breaks apart and releases its active drug in the body. • Tablets that fail this quality benchmark can delay or lessen the therapeutic effect, leaving blood-pressure levels inadequately controlled. Who uses chlorthalidone Chlorthalidone is a long-acting diuretic widely prescribed for hypertension and fluid retention tied to heart, liver, or kidney disease. Millions rely on the drug as a first-line, cost-effective option, often in combination with other antihypertensives. What patients should do now 1. Check your prescription bottle for the lot number and expiration date listed above. 2. Do NOT stop taking the medication without first consulting your physician; abrupt discontinuation may spike blood pressure. 3. If your bottle matches a recalled lot, call your pharmacy to arrange a replacement supply from unaffected inventory. 4. Contact Rising Pharma’s recall hotline or visit FDA.gov for return and refund instructions; pharmacies will coordinate bulk returns. Risk assessment The FDA has not yet assigned a recall classification (Class I, II, or III). No adverse events linked to these lots have been reported so far, but sub-potent doses can silently expose patients to heightened risks of stroke, heart attack, or kidney damage due to uncontrolled hypertension. Impact on supply and alternatives Industry analysts expect negligible market disruption because the recall affects only two lots and multiple generic manufacturers supply chlorthalidone. If shortages arise, clinicians can temporarily substitute alternative thiazide-type diuretics, such as hydrochlorothiazide or indapamide, while monitoring electrolyte balance. Regulatory backdrop The action follows a series of FDA enforcement efforts aimed at strengthening overseas manufacturing standards. The agency increased foreign facility inspections in 2026, focusing on dissolution testing compliance after several cardiovascular drugs—most notably certain extended-release metoprolol lots—failed similar quality checks earlier this year. How to stay informed Patients and healthcare providers can sign up for real-time recall alerts via the FDA’s MedWatch Safety Information system. Monitoring blood pressure at home and scheduling prompt follow-up visits are advisable for anyone who recently refilled chlorthalidone prescriptions. Key takeaway Prompt identification and replacement of the recalled chlorthalidone lots will help patients maintain stable blood-pressure control while the FDA and manufacturers strengthen quality safeguards.