FDA warns – Single lot of Digoxin Tablets USP in 0.125mg, 0.25mg recalled due to swapped labels

Marlex Pharmaceuticals, Inc., of New Castle, Delaware, has announced a voluntary, consumer-level recall of one lot of Digoxin Tablets USP, 0125mg, as well as one lot of Digoxin Tablets USP, 0.25mg, because the labels of both products have been mixed up, according to the FDA.

Officials say bottles bearing the label for Digoxin Tablets USP, 0.125mg, actually contain Digoxin Tablets USP, 0.25, and bottles marked for Digoxin Tablets USP, 0.25mg actually contain Dioxin Tablets UPS, 0.125 mg.

To mitigate risks of ingesting the wrong tablet, consumers are advised to note the actual physical characteristics of their intended tablet:

Digoxin Tablets USP, 0.125 mg

  • yellow, circular, beveled, uncoated
  • scored between “N” and “201” one one side, plain on the other

Digoxin Tablets USP, 0.25mg

  • white or off-white, circular, beveled, uncoated
  • scored between “N” and “202” on one side, plain on the other

A risk statement issued following Marlex Pharmaceuticals, Inc.’s recall announcement warns that the mislabeling creates a risk of overdose or under-dose in patients who take the wrong dose without awareness of the issue. Individuals who mean to take Digoxin Tablets USP, 0.125mg but who instead take the Digoxin in 0.25mg strength may suffer “significant drug toxicity,” often exhibited by “mental disorientation, dizziness, blurred vision, memory loss, and fainting.” Those intending to take Digoxin Tablets USP, 0.25mg, but who instead take the lower, 0.125mg, dose could potentially experience an uncontrolled heart rate and/or exacerbated heart failure.

Despite these potentially serious risks, Marlex Pharmaceuticals, Inc. has not been alerted to any reports of adverse reactions connected to the mix-up.

As a treatment for mild to moderate heart failure in both pediatric and adult patients, Digoxin “increases heart muscle contraction” in children and is also used to regulate ventricular response rate in adults with chronic atrial fibrillation (AF or AFib), a consistently irregular, often very rapid heart rhythm.

Distributed nationwide, Digoxin Tablets USP, labeled in either the 0.125mg or 0.25mg strength, are packaged 100 tablets to each white HDPE (high density polyethylene) bottle. Recalled products bear the following NDCs, lot numbers, and expiration date:

Digoxin 0.125mg Tablet

  • NDC 10135-0747-01, lot# E3810, expiration 2/2025

Digoxin 0.25mg Tablet

  • NDC 10135-0748-01, lot# E3811, expiration 2/2025

Marlex Pharmaceuticals, Inc. asks that consumers, distributors, and retail partners cease use and distribution of all products bearing the lot numbers listed above. Following the recall announcement, the company worked to alert its distributors and customers by email communication. A return program for all affected products was also being arranged.

Any questions about the recall may be directed to the company at 302-328-3355, or toll-free at 888-582-1953, Monday through Friday, from 8:30 a.m. to 4:30 p.m. Eastern Time. Anyone experiencing medical problems that may be linked to the usage of this drug should contact their healthcare provider.

At this time, the FDA continues to oversee the recall. Consumers who observe adverse reactions or quality issues connected to the product should report the incidents to the agency’s MedWatch program.


If you or a loved one has suffered an adverse health outcome that can be traced to the mislabeling of a medical drug, our experienced attorneys at TruLaw would like to help your family secure maximum compensation. After a distressing, potentially life-threatening medical event, you deserve justice and accountability from the responsible party. Connect with us online or try out our free Instant Case Evaluation ℠ to learn how we can support you in the legal process.