FDA recalls 11,460 chlorthalidone bottles
- The FDA issued a Class II recall for 11,460 bottles of chlorthalidone 25 mg after the product failed dissolution testing at a manufacturing site. - The recall affects the 25 mg strength and could lead patients to stop doses or present to hospital with missing medication during admission. - Nurses should ask about recalled products by name and lot when reconciling home meds to avoid unintended nonadherence in admitted patients. (medicaldaily.com)
Chlorthalidone, a prescription diuretic used to treat high blood pressure and fluid retention, is the subject of a U.S. recall affecting 11,460 bottles of the 25 mg strength after tablets failed dissolution specifications, according to FDA-linked recall reporting. Inventia Healthcare Limited initiated the recall on June 5, 2026, and the FDA classified it as a Class II recall on June 22. (medicaldaily.com) The recall covers two lots distributed nationwide in the United States: 100-count bottles with lot RISA24001 and 1,000-count bottles with lot RISB24002. The affected products carry National Drug Codes 64980-599-01 and 64980-599-10 and list an expiration date of April 2027. (medicaldaily.com) A failed dissolution result means the tablets may not break down as intended, which can affect how much medicine is available to the body. News reports citing the FDA said the issue arose after the product failed laboratory dissolution specifications at a manufacturing site. (medicaldaily.com) 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. In practical terms for this recall, the central risk is loss of blood-pressure control or interrupted therapy if patients stop taking the medicine and do not obtain a replacement. (medicaldaily.com) Patients should not stop chlorthalidone on their own solely because they hear about the recall. Medical Daily, citing the FDA notice, said patients with affected bottles should contact their pharmacist or prescriber about replacement medication or next steps. (medicaldaily.com) For hospitals and nurses, the recall matters during medication reconciliation. A patient may arrive saying a blood pressure medicine was recalled, may have stopped it at home, or may bring in a bottle that matches one of the recalled lots. Asking for the drug name, strength, lot number, and whether doses were missed can help identify unintended nonadherence. That implication is an inference based on the recall details and the specific lot-based scope of the action. (medicaldaily.com) The next practical step is straightforward: check whether the home medication is chlorthalidone 25 mg, then check the bottle for lot RISA24001 or RISB24002 and the April 2027 expiration date. If it matches, patients should contact the dispensing pharmacy or prescribing clinician for replacement guidance. (yahoo.com)
