A second recall of the blood pressure drug chlorthalidone is underway nationwide, this time covering 13,567 bottles of 25 mg tablets in 100-count bottles. India-based Inventia Healthcare Limited initiated the recall on Sept. 3 after the tablets failed dissolution specifications, and the FDA has classified it as a Class II recall, according to the FDA Enforcement Report.
The recall matters most to patients who checked their bottles in June and assumed they were in the clear. The September recall is separate from the June recall, so anyone who has refilled a chlorthalidone prescription since then may need to check again.
This is the second recall of the same drug and strength, from the same manufacturer, for the same reason, in about three months. That does not mean every chlorthalidone tablet is affected, but it gives patients and caregivers a reason to check each new bottle.
How to Check Your Bottle
The newly recalled product is Chlorthalidone Tablets USP, 25 mg, in 100-tablet bottles. The FDA enforcement report is the official source for the affected batch number and expiration date, so patients should compare the lot number printed on their label with the FDA listing or ask their pharmacist to confirm.
MedicalDaily previously reported on the June recall of 11,460 bottles. That recall covered batch RISA24001 in 100-count bottles and batch RISB24002 in 1,000-count bottles, both expiring in April 2027, according to FDA records reported by TODAY.
A notice filed with the California State Board of Pharmacy for the June recall said the problem surfaced during 18-month stability testing. The amount of active drug measured 91.5%, just under the approved range of 92% to 108%, and average dissolution was 78%, below the required 80%. The company said its preliminary assessment found no expected impact on patient health or safety. The September enforcement report cites failed dissolution, and MedicalDaily could not find the specific test values for the new batch.
Potency and Dissolution Failures in Plain Terms
Potency refers to how much active medicine a tablet contains. Dissolution measures how well that medicine is released from the tablet so the body can absorb it. A tablet can contain the right drug and still underperform if it does not dissolve properly.
After the June recall, Dr. Vivek Bhalla, a Stanford hypertension specialist, said a dissolution problem can make it harder for patients to receive the intended dose, which could leave blood pressure less well controlled.
A Class II recall means use of the product may cause temporary or medically reversible health effects, and the chance of serious harm is remote. The concern is reduced effectiveness, not contamination. Because high blood pressure usually causes no symptoms, a weaker pill would not necessarily feel any different.
Patients and Caregivers Most Affected
High blood pressure affects nearly 120 million U.S. adults, about 48%, according to the CDC. Chlorthalidone is a low-cost, widely used option. People who take it as their only blood pressure medicine, and those who use it for fluid buildup from heart failure or kidney disease, may be most affected if a dose underperforms.
Caregivers face a particular challenge. Pills moved into weekly organizers lose their labels, so the fastest check is to ask the pharmacy which batch was dispensed at each recent refill.
Patients should not stop taking chlorthalidone without talking to a clinician, since stopping a blood pressure drug suddenly carries its own risks. Reasonable steps include checking the lot number, calling the pharmacy about a replacement, and asking whether there is any cost for the exchange. People with a home monitor can track their readings and share any rise with their clinician. Severe headache, chest pain, vision changes, confusion, or trouble breathing require emergency care.
Neither the FDA nor the company has publicly explained why a second batch failed or whether more lots are under review. MedicalDaily will monitor the FDA enforcement database for further recalls.
Key Questions Answered
Which chlorthalidone bottles are in the new recall? Chlorthalidone Tablets USP, 25 mg, in 100-count bottles made by Inventia Healthcare. Check the lot number on your label against the FDA enforcement report or ask your pharmacist.
Is this the same recall as in June? No. The June recall covered batches RISA24001 and RISB24002. The September recall involves a separate batch.
Is the medication dangerous? The FDA classified the recall as Class II, meaning serious harm is unlikely. The main concern is that tablets may not release enough medicine to control blood pressure.
Should I stop taking chlorthalidone? No. Do not stop without speaking with your clinician or pharmacist, since stopping suddenly carries risks.
How do I check pills in a weekly organizer? Ask your pharmacy which batch number was dispensed with each recent refill.
When should I seek urgent care? Seek emergency care for severe headache, chest pain, vision changes, confusion, or trouble breathing.
