Digoxin Tablets Recalled Due to Cross Contamination with Mycophenolate Mofetil
Novitium Pharma LLC recalls Digoxin 125mcg tablets nationwide due to cross contamination with mycophenolate mofetil, a different medication. Patients receiving contaminated tablets could experience unintended drug effects.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Cross contamination with mycophenolate mofetil, a different pharmaceutical product, represents a risk-of-harm situation as patients may receive an incorrect medication with different therapeutic effects. This warrants a High severity score per the rubric, despite the FDA Class III classification.
Plain-English summary
Digoxin Tablets, USP 125 micrograms (0.125 mg) manufactured by Novitium Pharma LLC in 1000-count bottles are being recalled. The recall involves Lot #M23172A, expiring January 31, 2025. A total of 3,940 bottles have been recalled.
The recall was initiated due to cross contamination with mycophenolate mofetil, another pharmaceutical product. Digoxin and mycophenolate mofetil are different medications with different therapeutic purposes.
The recalled product was distributed nationwide in the USA.
Patients currently taking digoxin from the affected lot should immediately contact their pharmacy or healthcare provider to verify they are not using the recalled product. Patients should not discard their medication or change their treatment regimen without consulting a healthcare provider.
The recalled product
- Product
- DIGOXIN (DIGOXIN)
- Brand
- DIGOXIN
- Manufacturer
- Novitium Pharma LLC
- Category
- Drug
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: M23172A
- Exp 01/31/2025
UPCs (4)
- 0370954201106
- 0370954201205
- 0370954202103
- 0370954200109
Distribution
Distributed nationwide across the United States.
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