Digoxin Tablets Recalled Due to Failed Impurity and Degradation Specifications
Novitium Pharma LLC is recalling 1,003 bottles of Digoxin tablets (Lot M23011A, expiring 12/2024) distributed nationwide due to failed impurity and degradation specifications. Patients should consult their healthcare provider immediately.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class III recall for pharmaceutical specification failures with no reported illnesses or injuries. Per the severity rubric, FDA Class III recalls are typically scored 1 or 2; this specification failure warrants a Moderate (2) rating due to its quality control implications in a prescription medication.
Plain-English summary
Novitium Pharma LLC is recalling Digoxin Tablets, USP 62.5 mcg in 100-count bottles distributed nationwide. The affected product is Lot M23011A with an expiration date of 12/2024. Approximately 1,003 bottles have been distributed across the United States.
The recall was initiated because the tablets failed to meet established specifications for impurities and degradation. These failures indicate the product did not meet required pharmaceutical quality standards.
Patients taking this medication and who have bottles from Lot M23011A should contact their healthcare provider immediately. Do not discontinue use without medical advice, as abrupt cessation of this cardiac medication could be harmful. Pharmacists and healthcare providers should check their inventory against the affected lot number and expiration date and take appropriate action regarding affected patients.
The recalled product
- Product
- DIGOXIN (DIGOXIN)
- Brand
- DIGOXIN
- Manufacturer
- Novitium Pharma LLC
- Category
- Drug — Cardiac Glycoside
- Affected units
- 1,003
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 M23011A
- Exp. 12/2024
UPCs (4)
- 0370954201106
- 0370954201205
- 0370954202103
- 0370954200109
Distribution
Distributed nationwide across the United States.
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