The FDA has issued a Class II recall of chlorthalidone blood pressure tablets after more than 13,000 bottles failed dissolution testing.
When a medicine fails a dissolution test, it means the pill didn’t break down and dissolve properly in the body as it should, making it less effective at treating patients’ conditions. Dissolution is necessary for it to be absorbed properly in the body.
Inventiva Healthcare Limited initiated the recall on September 3, and the FDA classified it on September 17. A class II designation implies that the product may cause temporary or medically reversible health issues, but the probability of serious harm is considered remote.
The recall covers a total of 13,567 bottles of Chlorthalidone tablets, USP, 25 mg (NDC: 64980-599-01, Batch no., RISA24002, expiration date: April, 2027), distributed nationwide.
Since the tablets have reduced efficiency, it can increase the risk of heart attack, stroke, kidney damage, or other complications over time.
This marks the second recall of the medicine this year. Earlier in June, the company recalled 11,460 bottles of the same medication in 100-tablet and 1,000-tablet sizes for the exact reason. That recall was also classified as Class II.
2026-09-28 23:38:00
