A potentially life threatening label mistake caused Marlex Pharmaceuticals to recall two lots of heart failure medication Digoxin.
Here’s what you need to know.
What Digoxin tablets are recalled?
Digoxin 0.125 mg tablets, lot No. E3810, expiration 2/2025, NDC No. 10135-0747-01. These Digoxin tablets are described as “yellow, circular, beveled, uncoated tablets” with a plain side and a side with “N” and “201” split by a line.
Digoxin 0.25 mg tablets, lot No. E3811, expiration 2/2025, NDC No. 10135-0748-01. These tablets should be white or off-white, circular, uncoated, plain on one side and, on the other side, “N” and “202” split by a line.
Why are those two lots of Digoxin tablets being recalled?
A straight up, simple mixup — bottles labeled as having Digoxin 0.125 mg tablets have 0.25 mg tablets and bottles labeled as having 0.25 mg tablets have 0.125 tablets.
As Marlex explains in the risk statement of its recall notice, the person taking too strong of a dose, “can experience significant drug toxicity (mental disorientation, dizziness, blurred vision, memory loss and fainting) from the unintentional overdose.”
Taking too weak a dose, “may lead to loss of control of heart rate and potential heart failure exacerbation.”
What should you do now?
Stop using the drugs and return them to the pharmacy where you bought them.
If you have had any medical problems from this or any other drug, see a medical professional. Then let the FDA know via its MedWatch Adverse Event page or by filling out a form you can get by calling 800-332-1088.
If you have questions about this recall, phone Marlex at 302-328-3355 or 888-582-1953, Monday through Friday, 8:30 a.m. to 4:30 p.m., Eastern time.