Fda chlorthalidone dissolution testing recall

On 14 September 2026, the U.S. Food and Drug Administration announced a voluntary nationwide recall of specific lots of Chlorthalidone tablets, a medication primarily used to treat hypertension and edema. The recall was initiated after routine quality control testing revealed that the affected batches failed to meet established dissolution specifications. Dissolution testing is a critical regulatory requirement that ensures a drug product releases its active ingredient into the body at the appropriate rate to achieve therapeutic efficacy. The manufacturer identified that the tablets in the recalled lots may not dissolve as intended, which could lead to inconsistent absorption and potentially sub-therapeutic levels of the medication in patients. While the company stated that there have been no reports of adverse events directly linked to this issue as of 14 September 2026, the recall is being conducted as a precautionary measure to ensure patient safety. Healthcare providers have been instructed to stop distributing the affected lots, and patients are advised to consult their physicians regarding alternative treatment options or replacement medication.