The US Food and Drug Administration classified a nationwide recall of chlorthalidone blood pressure tablets as Class II on September 17, 2026, after the pills failed to dissolve properly during quality testing.
What's Being Recalled
Inventia Healthcare Limited, based in Mumbai, India, is voluntarily recalling 13,567 bottles of 25 mg chlorthalidone tablets nationwide. The affected bottles carry batch number RISA24002 and an expiration date of March 2027. The recall was firm-initiated, meaning Inventia Healthcare triggered the action itself rather than being compelled by regulators, and was first announced on September 3 before receiving its formal FDA classification two weeks later.
Why the Pills Were Pulled
The tablets failed a dissolution test, which measures how well a tablet breaks down and releases its active ingredient once inside the body. When a drug fails this test, it may not be absorbed properly, which can reduce its effectiveness in managing blood pressure and fluid retention.
What Class II Means
The FDA defines a Class II recall as a situation in which exposure to the product "may cause temporary or medically reversible adverse health consequences," or where the probability of serious adverse health consequences is remote. It's the FDA's second-highest risk classification, one tier below Class I, which is reserved for situations where a product could cause serious health consequences or death — the category used, for example, in August's recall of 1.6 million cartons of potentially salmonella-tainted eggs.
What Chlorthalidone Treats
Chlorthalidone is a diuretic, sometimes called a water pill, used to treat high blood pressure. According to the Cleveland Clinic, it helps the kidneys remove more fluid and salt from the blood through urine, and may also be used to reduce swelling related to heart, kidney, or liver disease.
Not the First Time for This Product
This latest recall follows an earlier one by the same manufacturer in June 2026, when Inventia Healthcare recalled 11,460 bottles of the same blood pressure medication, also over dissolution failures — meaning this marks the second time this year the company has had to pull chlorthalidone tablets from shelves for the identical underlying quality issue.
What the FDA Says Patients Should Do
Crucially, the FDA is not advising patients to simply stop taking the medication if they have affected bottles. The agency has warned in similar recalls that "stopping your medicine may be more harmful to your health than continuing to take the recalled medicine." Patients with 25 mg chlorthalidone tablets are advised to check their prescription bottle for the batch number and expiration date, and to speak with their doctor or pharmacist before making any changes to how they take this or any other prescribed medication.
A Separate, Unrelated Blood Pressure Recall Earlier This Year
This chlorthalidone recall is distinct from an earlier, separate recall affecting a different blood pressure drug: Teva Pharmaceuticals and Amerisource Health Services issued a voluntary recall of more than 580,000 bottles of various strengths of prazosin hydrochloride capsules, also classified as Class II, over concerns the medication could contain nitrosamine impurities — chemicals with the potential to cause cancer that can form during a drug's storage or production. Both recalls illustrate the range of quality issues, from dissolution failures to chemical contamination, that can trigger FDA Class II designations for widely prescribed medications.
What's Next
Patients concerned about whether their specific bottle of chlorthalidone is affected should check the lot number and expiration date against the recall notice, and contact their pharmacy or prescribing doctor with any questions before altering their medication routine. For the full FDA recall notice, see the FDA's official recall database.
This article is for informational purposes only and is not medical advice. Do not stop taking a prescribed medication without first consulting your doctor or pharmacist.