Marlex Pharmaceuticals recalled two lots of digoxin tablets, which are used to treat heart failure, because of swapped labels for the 0.25 milligram and 0.125 milligram solutions, the FDA said Aug. 31.
A patient can either unknowingly overdose, which can cause dizziness, memory loss and fainting, or underdose, which can exacerbate heart failure.
The New Castle, Del.-based drugmaker has not reported any adverse events related to the product removal.