Digoxin Tablets recall
FDA recall D-0389-2024 · initiated Mar 4, 2024
Novitium Pharma LLC recalled Digoxin Tablets in Mar 2024 — an FDA Class III recall (D-0389-2024) because Cross Contamination with Other Products:(mycophenolate mofetil).
Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
Why it was recalled
Cross Contamination with Other Products:(mycophenolate mofetil).
Something got into the product
A physical or chemical contaminant was found — glass or metal fragments, or a solvent that should not be there.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 3,940 1000-count bottles
Details
- Product
- Digoxin Tablets, USP 125mcg, (0.125 mg), 1000-count bottle, Rx Only, Manufactured by: Novitium Pharma LLC., 70 Lake Drive, East Windsor, New Jersey 08520, NDC 70954-201-20
- Recalling company
- Novitium Pharma LLC
- Classification
- Class III
- Status
- Terminated
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA
- Initiated
- Mar 4, 2024
- FDA report date
- Mar 27, 2024
Frequently asked
- Was Digoxin Tablets recalled?
- Novitium Pharma LLC recalled Digoxin Tablets in Mar 2024 — an FDA Class III recall (D-0389-2024) because Cross Contamination with Other Products:(mycophenolate mofetil). Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
- Why was Digoxin Tablets recalled?
- Per the FDA enforcement record, the reason for recall D-0389-2024 was: Cross Contamination with Other Products:(mycophenolate mofetil).
- Is a recalled Digoxin Tablets dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Unlikely to cause harm but violates FDA labeling or manufacturing regulations. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Digoxin Tablets are affected?
- Distributed: Nationwide in the USA. The recall covers these lots — Lot #: M23172A, Exp 01/31/2025. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0389-2024.