Two Chlorthalidone Recalls Cover More Than 25,000 Bottles
Two recalls of 25 mg chlorthalidone tablets in 2026 affect a combined 25,027 bottles, according to U.S. Food and Drug Administration enforcement reports. The tablets, made by Inventia, failed quality tests related to how the medication dissolves. The FDA classified both actions as Class II recalls, a category indicating that temporary health effects are possible but serious harm is unlikely.
The September 3 recall covers 13,567 bottles from batch RISA24002, packaged in 100-tablet bottles with National Drug Code (NDC) 64980-599-01. An earlier recall, initiated June 5, covers 11,460 bottles across two batches: RISA24001, also in 100-tablet bottles with the same NDC, and RISB24002, in 1,000-tablet bottles with NDC 64980-599-10. All three batches expire in April 2027. The tablets are light yellow, round and flat, with “103” stamped on one side.
Chlorthalidone is a diuretic prescribed for high blood pressure and fluid retention. Dissolution testing measures how a tablet releases its active ingredient. If the drug does not dissolve as expected, the body may absorb less of it, potentially reducing its effectiveness. The September report does not specify how that batch failed testing. In a notice concerning the June recall, distributor Rising Pharma Holdings said testing found the tablets contained 91.5% of the labeled amount of chlorthalidone, below the 92% minimum. An average of 78% dissolved in testing, below the required 80%. The distributor said it did not anticipate an impact on patient health and safety from the June recall.
The recalls are at the retail level. Patients who think their supply might be affected can ask their pharmacy to check the manufacturer, NDC and batch number. They should consult their pharmacist about a replacement and whether to keep taking their medication rather than stopping abruptly. The FDA says stopping treatment unnecessarily can pose greater risks than continuing a recalled medication.