A nationwide blood pressure medication recall is raising concern because the issue is not just about a mislabeled bottle; it could mean some patients are not getting the full effect of a drug they rely on daily.
The FDA has recalled 11,460 bottles of Chlorthalidone Tablets, USP, 25 milligrams, after the medication failed to meet “failed dissolution specifications.” In simple terms, dissolution testing checks how well a tablet breaks down and releases medicine once it reaches the body. The FDA’s own guidance explains that drug absorption from a solid oral dosage form depends on the drug being released and dissolved properly under physiological conditions.
That makes this recall especially important for people taking chlorthalidone to manage high blood pressure. Mayo Clinic describes chlorthalidone as a diuretic, or water pill, that helps the body get rid of extra water and salt through urine, which can help lower blood pressure. It is also used to treat fluid retention linked to conditions such as congestive heart failure, liver disease, kidney disease, or certain hormone and steroid treatments.
The recalled bottles include 100-tablet and 1,000-tablet bottles with batch numbers RISA24001 and RISB24002. Both have an expiration date of April 2027. The tablets were manufactured by Inventia Healthcare Limited in India and distributed by Rising Pharma Holdings, Inc. in East Brunswick, New Jersey.
The danger is that an ineffective blood pressure medication can quietly leave someone unprotected. High blood pressure is often called a silent condition because many people do not feel symptoms while damage is building. The CDC says high blood pressure is also more common among non-Hispanic Black adults, affecting 59.6%, compared with 44.9% of Hispanic adults, 44.8% of non-Hispanic white adults, and 42.7% of non-Hispanic Asian adults. The CDC warns that the higher a person’s blood pressure levels are, the higher their risk becomes for heart disease, heart attack, and stroke. The American Heart Association also notes that uncontrolled high blood pressure can contribute to heart failure, kidney disease or failure, vision loss, plaque buildup in the arteries, and other serious health problems.
This recall also comes roughly one month after another blood pressure medication, Amlodipine and Olmesartan Medoxomil Tablets, was recalled over failed dissolution specifications. That recall involved 15,696 bottles and was classified as Class II, according to Pharmacy Learning Network.
The FDA defines a Class II recall as “a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
Anyone who believes they may have a recalled bottle should check the batch number, contact their pharmacist or healthcare provider, and avoid stopping prescribed blood pressure medication without medical guidance.
