FDA recalls 11,000 blood pressure bottles over a troubling defect

The FDA has expanded its action by recalling 11,460 bottles of chlorthalidone tablets, highlighting ongoing concerns about dissolution failures in hypertension medications. The recall covers two 25-milligram packaging formats produced by Inventia Healthcare Limited of India and distributed by Rising Pharma Holdings, Inc., based in New Jersey. Specifically, 100-tablet bottles carry national drug code 64980-599-01 with batch code RISA24001, and 1,000-tablet bottles carry NDC 64980-599-10 with batch code RISB24002; both batches have an expiration date of April 2027. The withdrawal, which began on June 5, was detailed in an FDA report dated June 12. The underlying defect is failed dissolution specifications, meaning some samples do not dissolve as intended, potentially delivering a lower dose of the active ingredient. For patients, this recall underscores the risk that an under-dosed antihypertensive could leave blood pressure inadequately controlled, increasing risk of heart disease and stroke. Patients prescribed Chlorthalidone Tablets, USP should check recalled packaging and batch codes, and contact their physician or pharmacist promptly to verify eligibility and discuss next steps. Do not stop taking a prescribed medication abruptly; the FDA emphasizes a managed transition to an unaffected product if needed. The recall illustrates the global reach of pharmaceutical supply chains and regulatory vigilance in protecting patient safety.