The Food and Drug Administration (FDA) has announced a recall of specific lots of spironolactone (Bryant Ranch Prepack) tablets due to mislabeling; affected product labels may display the incorrect strength. Prepackaged bottles labeled spironolactone 50 mg may contain spironolactone 25 mg tablets and prepackaged bottles of spironolactone 25 mg may contain spironolactone 50 mg tablets.
Spironolactone is indicated as a diuretic in the treatment of high blood pressure, heart failure, hypokalemia, and edema. A patient who consumes spironolactone 25 mg instead of the prescribed spironolactone 50 mg may experience an elevation in blood pressure or increased swelling caused by excess fluid if taking the product chronically. It is possible that patients could experience a decrease in potassium if taking half of the expected dose which could lead to hypokalemia, a condition associated with cardiac arrhythmias. Furthermore, patients who consume spironolactone 50 mg instead of the prescribed spironolactone 25 mg could experience an increase in potassium which could be life-threatening.
As of the notice of recall, Bryant Ranch Prepack has not received any reports of adverse events related to this recall.
Food and Drug Administration (FDA). Bryant Ranch Prepack Issues Voluntary Nationwide Recall of Spironolactone 25 mg and 50 mg Tablets Due to Mislabeling with the Incorrect Strength (Revision to Press Release with Same Title Dated 3/9/2021. Revision Includes Number of Bottles Impacted by Recall) [news release]. March 9, 2021. Available at: click here. Accessed March 11, 2021.