Inventia Recalls Chlorthalidone After FDA Dissolution Test Failure

The U.S. Food and Drug Administration has classified a nationwide Class II recall of chlorthalidone blood pressure tablets made by Inventia Healthcare Limited as a second instance involving the same manufacturer due to quality testing failures. The voluntary recall, initiated in September, covers 13,567 bottles containing 25 mg dosage pills that failed dissolution tests and do not dissolve properly within the body.

Inventia Healthcare previously recalled over 11,400 bottles of this product in June for identical issues. Chlorthalidone is widely used to treat high blood pressure and fluid retention according to Mayo Clinic. The affected tablets have a National Drug Code of 64980-599-01 with an expiration date set for April 2027.

The FDA defines the Class II classification as a situation where use or exposure may cause temporary or medically reversible adverse health consequences, though serious outcomes are considered remote. The manufacturer is based in India and has not yet provided further comment to Fox Business regarding this second recall.