Recall Overview
The U.S. Food and Drug Administration (FDA) has announced a nationwide recall of 11,460 bottles of Chlorthalidone Tablets (25 mg), a common medication used to treat hypertension and fluid retention. The recall was initiated by the manufacturer, Inventia Healthcare Limited, on June 5 following the discovery of a dissolution failure during regulatory testing.
A dissolution failure indicates that the tablets may not break down correctly in the patient’s digestive system. This defect can lead to inconsistent absorption of the active ingredient, potentially rendering the medication ineffective for patients managing chronic blood pressure conditions or fluid retention associated with heart, kidney, or liver disease.
Affected Lots and Distribution
The affected products were distributed by Rising Pharma Holdings Inc., based in East Brunswick, New Jersey. The recall specifically covers two batch numbers, both with an expiration date of April 2027:
- Lot RISA24001: 100-count bottles.
- Lot RISB24002: 1,000-count bottles.
As of this reporting, the FDA has not issued a formal classification for the recall, and specific potential health risks for patients who have already consumed the affected tablets remain under investigation.
Guidance for Patients
Medical professionals advise patients not to abruptly discontinue their blood pressure medication, as sudden cessation can lead to dangerous spikes in blood pressure. Patients concerned that their prescription may be part of the recalled batches are urged to contact their pharmacist or prescribing physician to verify their medication and discuss potential alternatives.
This recall marks the second instance of a blood pressure medication recall in the United States within the last month due to dissolution-related issues, following a May 5 recall of Amlodipine and Olmesartan Medoxomil tablets.