Cross-Contamination Prompts Heart Drug Recall

Novitium Pharma is recalling 3940 bottles of digoxin tablets because of cross-contamination with the immunosuppressant mycophenolate mofetil, according to the March 27, 2024, US Food and Drug Administration (FDA) Enforcement Report.

The recall affects digoxin tablets, 125 mcg (0.125 mg), in 1000-count bottles (NDC 70954-201-20), from lot M23172A (Exp. 1/31/25). The tablets were distributed throughout the United States. 

Novitium Pharma voluntarily initiated the recall on March 4, 2024. The FDA designated the recall Class III on March 15, 2024. Per the classification, use of the affected tablets is not likely to cause harm.

Digoxin is a prescription medication with indications for heart failure in adults and children and atrial fibrillation in adults.