Spironolactone recalled after mix-up puts wrong doses in dozens of bottles

Brittany A. Roston - Mar 14, 2021, 2:28pm CDT
Spironolactone recalled after mix-up puts wrong doses in dozens of bottles

Spironolactone, a drug used to treat various health matters, has been recalled after the manufacturer behind the product discovered mislabeling that puts patients at risk of getting the wrong dose. Nearly four dozen bottles of the medication have been recalled, according to a notice recently published by the FDA.

The new recall comes from Bryant Ranch Prepack, which voluntarily recalled its BRP Pharmaceuticals spironolactone tablets sold in 25mg and 50mg strengths. The reason, according to the recall notice, is a mislabeling issue that may result in patients getting the wrong dose.

The recalled bottles labeled with 25mg strength tablets may contain 50mg strength tablets; likewise, the bottles labeled with 50mg strength tablets may actually contain 25mg strength. The potential consequences of taking the wrong dose depend on the patient’s condition but may include things like changes in blood pressure and an increase or decrease in potassium levels.

The recalled 50mg-labeled spironolactone products come from a single lot, while the 25mg-labeled recalled tablets come from three lots. The FDA lists the lot number, expiration dates, and NDC numbers for the recalled drugs on its website here.

Consumers who may have taken these recalled products are advised to contact their doctors if they experience any issues possibly related to the tablets. The company is notifying both consumers and distributors about the recall. Bryant Ranch Prepack is also accepting calls from consumers who have questions about the recall.


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