More than 13,500 bottles of a widely used blood pressure medication are being pulled from shelves nationwide after failing a key quality test — the second time in three months that pills from the same manufacturer have run into this exact problem. The Food and Drug Administration announced the recall of the 25 mg chlorthalidone tablets, made by Inventia Healthcare Limited, after the product failed dissolution specifications, according to a report from Boston 25 News.
The FDA issued the initial recall on September 3 and classified it as a Class II action on September 17, per Boston 25 News. The affected pills came in 100-count bottles distributed nationwide, carrying NDC number 64980-599-01, batch number RISA24002, and an expiration date of April 2027. A Class II recall means use of or exposure to the product may cause temporary or medically reversible health problems, or that serious harm is remotely probable, the outlet reported.
A Second Failure for the Same Chlorthalidone Line
This is not the first time Inventia's chlorthalidone tablets have run afoul of FDA dissolution testing. Back in June, Rising Pharma Holdings distributed the same type of chlorthalidone medication that was recalled for the identical issue — failed dissolution specifications — according to Boston 25 News. Hoodline previously reported on that recall, which involved 11,460 bottles across lots RISA24001 and RISB24002 and had not yet received a formal FDA classification when Hoodline reported on June 22.
As reported by NTD News, that June recall stemmed from the same manufacturing pipeline: Inventia Healthcare Limited makes the tablets, while Rising Pharma Holdings, Inc. handles U.S. distribution. Corporate filings reviewed by International Business Times show Inventia is based in Mumbai, India, while Rising Pharma is headquartered in East Brunswick, New Jersey. Both recalls involved failed dissolution specifications.
What Dissolution Failure Actually Means
Dissolution testing measures the rate and extent to which an active drug ingredient dissolves in liquid. When tablets fail those specifications, it means they may not break down properly in the body, which can lead to incomplete absorption and reduced effectiveness. For a blood pressure medication, that translates to pills that may simply not work as intended, even though patients are taking them exactly as prescribed.
Chlorthalidone itself is a diuretic, or water pill, used to treat high blood pressure and fluid retention caused by congestive heart failure, severe liver disease, or kidney disease, per Boston 25 News.
Doctors Warn Against Stopping Medication Abruptly
Despite the recall, medical experts are urging patients not to panic or quit their medication on their own. The American Heart Association advises patients taking recalled hypertension drugs to never stop their prescribed doses abruptly without consulting a doctor first, since sudden discontinuation can trigger dangerous blood pressure spikes and raise the risk of heart attack or stroke. That guidance underscores a real tension for patients: the pills may be under-delivering their intended effect, but stopping cold turkey carries its own serious dangers.
Patients should check their bottles against the affected lot numbers.
Part of a Broader Pattern in Generic Drug Recalls
This recall also fits into a wider trend across the generic pharmaceutical industry. In May, Ascend Laboratories recalled 15,696 bottles of amlodipine and olmesartan medoxomil tablets — another blood pressure drug combination — for the identical reason: failed dissolution specifications, according to a report from Quartz. Failed dissolution specifications represented the single leading cause of U.S. drug recalls between 2020 and 2023, per FDA enforcement tracking cited by NTD News.
In October 2025, for example, the FDA issued a Class II recall of more than 580,000 bottles of prazosin hydrochloride due to elevated levels of potentially carcinogenic nitrosamine impurities, according to CBS News. The current run of dissolution failures suggests regulators may be turning up scrutiny on how generic drug importers, particularly those relying on overseas manufacturing, verify their products actually work as intended before they reach American pharmacy shelves.
