FDA Urgent Recall: Over 13,000 Bottles of Chlorthalidone Blood Pressure Tablets Pulled—Is Your Medication on the List?

Updated: September 28 2026 Millions of Americans who rely on the diuretic chlorthalidone to control high blood pressure are being urged to check their medicine cabinets after the U.S. Food and Drug Administration (FDA) announced a nationwide Class II recall of specific 25 mg chlorthalidone tablets. What’s being recalled • Product: Chlorthalidone Tablets USP, 25 mg • Presentation: Bottles of 100 and 1,000 tablets • Lot/Batch numbers: RISA24001 (100-count) and RISB24002 (1,000-count) • Expiration date: 04/2027 • Manufacturer: Inventia Healthcare Ltd. (India) • Distributor: Rising Pharma Holdings, Inc. (East Brunswick, NJ) Reason for the recall Routine quality-control testing showed that the affected tablets failed “dissolution specifications,” meaning they may not dissolve properly in the body. Inadequate dissolution can delay or reduce absorption of chlorthalidone, potentially leading to uncontrolled blood pressure or fluid retention in patients who depend on consistent dosing. Health risks While no injuries or adverse events have been reported so far, sub-therapeutic levels of chlorthalidone can raise the risk of stroke, heart attack, and hospitalization in people with hypertension or congestive heart failure. Patients with kidney or liver disease who use the drug to manage edema may also experience worsening swelling. What patients should do 1. Locate the National Drug Code (NDC) and lot number on your prescription label or the bottle’s side panel. 2. If the bottle matches the recalled lots, stop using the medication only after speaking with your pharmacist or prescribing physician; abrupt discontinuation can spike blood pressure. 3. Contact Rising Pharma’s recall hotline at 1-866-XYZ-1234 for instructions on returning or safely disposing of the product and obtaining a replacement. 4. Monitor your blood pressure daily until you have a confirmed, unaffected supply. Report any side effects—such as dizziness, rapid weight gain, or swelling of the legs—to your healthcare provider and to FDA’s MedWatch program at 1-800-FDA-1088. Pharmacy guidance Retailers and wholesalers are instructed to quarantine remaining inventory from the affected lots and arrange for return shipping with Inmar Rx Solutions, the recall coordinator. Reimbursement will be issued upon receipt and verification of the returned goods. Safe alternatives Chlorthalidone is part of the thiazide-like diuretic class. Patients may discuss switching to therapeutic equivalents such as hydrochlorothiazide or indapamide if inventory shortages occur; however, dosage conversions should be managed by a clinician. Why this matters Chlorthalidone has been on the market for more than 60 years and is listed on multiple evidence-based guidelines as a first-line antihypertensive. Any disruption in supply can therefore affect millions of prescriptions each year. Staying informed and acting promptly minimizes the risk of uncontrolled blood pressure and associated cardiovascular events. For future recall alerts, sign up for FDA’s email notifications or download the FDA Recall mobile app, which provides real-time updates on drug, medical device, and food safety notices.