Class III · Low risk
Digoxin Tablets
Cross Contamination with Other Products:(mycophenolate mofetil).
Digoxin Tablets
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed Impurities/Degradation Specifications
Cause type: Impurity / degradation
An impurity or degradation product above its limit - other than nitrosamines. Unexpected substances in a batch can make it unsafe or less effective, even when the active ingredient is present. All impurity / degradation recalls.
What was recalled
Digoxin Tablets, USP 62.5 mcg (0.0625 mg), 100-count bottles, Rx Only, Manufactured by: Novitium Pharma LLC, 70 Lake Drive, East Windsor, New Jersey 08520, NDC 70954-200-10
Affected NDC
70954-0200-10
Compare with the code on your package — it is the most precise check available.
Drug: Digoxin
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Digoxin NDC 70954-0200 |
.0625 mg/1 | Tablet Oral |
ANI Pharmaceuticals, Inc. | Rx |
- Recalling firm
- Novitium Pharma LLC
- NDC code
- 70954-200-10
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0443-2024 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Digoxin recalls
See all
Class II · Moderate risk
Digoxin Tablets
Labeling: Label Mix-Up- Bottles labeled as Digoxin Tablets, USP 0.125 mg contain Digoxin Tablets, USP 0.25mg and bottles labeled as Digoxin Tablets, USP 0.25mg contain Digoxin Tablets, USP 0.125mg.
Class I · High risk
Digoxin Tablets
Labeling: Label Mix-Up- Bottles labeled as Digoxin Tablets, USP 0.125 mg contain Digoxin Tablets, USP 0.25mg and bottles labeled as Digoxin Tablets, USP 0.25mg contain Digoxin Tablets, USP 0.125mg.
Class II · Moderate risk
Digoxin active pharmaceutical ingredient packaged in varying grams or kg in bags or drums
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Class II · Moderate risk
Digoxin
Labeling: Label Mixup: DIGOXIN, Tablet, 125 mcg may have potentially been mislabeled as the following drug: CHOLECALCIFEROL/ CALCIUM/ PHOSPHORUS, Tablet, 120 units/105 mg/81 mg, NDC 64980015001, Pedigree: W002581, EXP: 6/3/2014.
Other recalls by Novitium Pharma LLC
All 2024 recalls
Class III · Low risk
Digoxin Tablets
Cross Contamination with Other Products:(mycophenolate mofetil).
Class II · Moderate risk
Novitium Pharma Ranitidine Capsules 300 mg 100 capsules Rx Only…
CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk
Novitium Pharma Ranitidine Capsules 300 mg 30 capsules Rx Only…
CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk
Novitium Pharma Ranitidine Capsules 150 mg 500 capsules Rx Only…
CGMP Deviations: Presence of NDMA impurity detected in product.
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