Chlorthalidone Recall: How to Check Your Tablets and What the Dissolution Failure Means
The U.S. Food and Drug Administration has posted two recall notices for 25 mg chlorthalidone tablets made by Inventia Healthcare Limited, a manufacturer based in India. Together, the recalls involve more than 25,000 bottles. The reason: the medication failed dissolution specifications.
Chlorthalidone is a diuretic, or water pill, that lowers blood pressure by increasing urine flow. That reduces the amount of water and salt in the body, according to the Mayo Clinic. If a tablet dissolves too slowly, the body may not get the intended dose at the right time. For a daily blood pressure medicine, that can make treatment less consistent.
What went wrong? The FDA tests some drugs for dissolution to confirm they release their active ingredient correctly. Inventia's chlorthalidone tablets did not meet those specifications. The problem is not contamination; it is a quality control issue. The active ingredient may still be present, but its release in the body could be unpredictable.
Which bottles are affected? The recall covers 25 mg strength chlorthalidone tablets sold in 100-tablet and 1,000-tablet bottles. The affected batch codes are RISA24001, RISB24002 and RISA24002. The tablets expire in April 2027. The FDA recall numbers are D-0610-2026 and D-0852-2026. Inventia's first recall affected 11,460 bottles. The second covered 13,567 bottles.
How to check your prescription? Begin with the label. Look for chlorthalidone, confirm the strength is 25 mg, and then find the lot or batch code printed on the bottle. Compare it to the three codes above. A patient whose bottle matches should not toss it yet, and should not stop taking the medicine. The FDA has classified both recalls as Class II. For Class II and III recalls, the FDA says stopping a medicine may sometimes be more harmful than continuing it while you get advice.
The next step is to contact a doctor or pharmacist. They can confirm whether the lot code is affected and recommend what to do. In many cases, a pharmacist can look up the manufacturer and lot from the prescription records, so bring the bottle when asking. The safest move is to get professional guidance before changing a daily medication. If a patient has already taken tablets from an affected lot, the same advice applies: speak with a clinician rather than deciding on your own.
Keep the original container until you receive instructions. The label carries the information a pharmacy or prescriber needs to identify the product. Patients who do not find a matching batch code on their bottle can likely continue taking the medicine, but they can double-check with their pharmacy. This recall is a reminder that blood pressure medicines are not interchangeable without oversight, and a failed dissolution test is one reason regulators pull a drug off the market.