FDA MedWatch - Spironolactone 25 mg and 50 mg Tablets by Bryant Ranch Prepack: Recall - Due to Mislabeling with the Incorrect Strength

MedWatch - The FDA Safety Information and Adverse Event Reporting Program TOPIC: Spironolactone 25 mg and 50 mg Tablets by Bryant Ranch Prepack: Recall - Due to Mislabeling with the Incorrect Strength AUDIENCE: Patient, Health Professional, Risk Manager, Pharmacy ISSUE: Bryant Ranch Prepack is recalling 4 lots of spironolactone tablets because the products have been found to be mislabeled, displaying 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. 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 (edema) 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. Patients with renal insufficiency or those taking concomitant renin-angiotensin-aldosterone system (RAAS) inhibitors would be at increased risk. As of 3/9/2021 Bryant Ranch Prepack has not received any reports of adverse events related to this recall. For more information about this recall click on the red button "Read Recall" below. BACKGROUND: Spironolactone is indicated as a diuretic in the treatment of high blood pressure, heart failure, hypokalemia, and edema. RECOMMENDATION: Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: Complete and submit the report online. Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

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