FDA Issues Class II Recall on Blood Pressure Drug Over Failed Dissolution
The U.S. Food and Drug Administration has issued a Class II recall of Chlorthalidone Tablets USP (25 mg), a widely used blood pressure medication, affecting 13,567 bottles distributed nationwide. The Hill
The recall, initiated in September 2026, was triggered by failed dissolution specifications, meaning the active ingredient does not properly dissolve from the tablet as required, potentially rendering the medication ineffective for patients managing hypertension.
The affected product is manufactured by India-based Inventia Healthcare Limited and is identified by NDC 64980-599-01, Batch RISA24002, expiring April 2027. Under FDA’s Class II classification, use of the product “may cause temporary or medically reversible adverse health consequences,” though serious risk is considered remote.
Critically, this marks the second recall of this same medication for the same reason within months, following a June 2026 recall that affected over 11,000 bottles.
Patients currently taking Chlorthalidone are advised to check their bottle’s NDC number and batch code against the recalled details. Anyone with a matching batch should contact their pharmacist or healthcare provider before discontinuing the medication.
With hypertension affecting approximately 48% of Americans, medication reliability is a public health priority and repeated recalls from the same manufacturer raise serious quality control questions.
Read our previous article on medical and health related topics here.
