CLASS III Drug recall · Reported 24 Apr 2024 · FDA Enforcement Report
Digoxin Tablets, USP 62.5 mcg (0.0625 mg) recalled by Novitium Pharma
Novitium Pharma is recalling Digoxin Tablets, USP 62.5 mcg (0.0625 mg), distributed nationwide in the US. The recall was initiated on 25 Mar 2024 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0443-2024
- FDA event ID
- 94255
- Recalling firm
- Novitium Pharma, East Windsor, NJ
- Brand
- Digoxin
- Manufacturer
- ANI Pharmaceuticals, Inc.
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 25 Mar 2024
- FDA classified
- 13 Apr 2024
- Reported
- 24 Apr 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 25 Mar 2024 | Recall initiated by company | |
| 13 Apr 2024 | Classified by FDA | +19 days |
| 24 Apr 2024 | Published in enforcement report | +11 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Impurities/Degradation Specifications
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
U.S. Nationwide
Questions about this recall
Why was it recalled?
Failed Impurities/Degradation Specifications
Which lots are affected?
Lot M23011A; Exp. 12/2024
Where was it sold?
U.S. Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Novitium Pharma
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Digoxin Tablets, USP 125mcg, (0.125 mg) recalled by Novitium PharmaDigoxin | Novitium Pharma | Other | Nationwide |
| Drug | CLASS II | Ranitidine Capsules 300 mg recalled by Novitium Pharma | Novitium Pharma | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Ranitidine Capsules 300 mg recalled by Novitium Pharma | Novitium Pharma | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Ranitidine Capsules 150 mg recalled by Novitium Pharma | Novitium Pharma | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Ranitidine Capsules 150 mg recalled by Novitium Pharma | Novitium Pharma | Nitrosamine Impurity | Nationwide |
Other Digoxin recalls
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Digoxin Tablets, USP 125mcg, (0.125 mg) recalled by Novitium PharmaDigoxin | Novitium Pharma | Other | Nationwide |
| Drug | CLASS I | Digoxin Tablets, USP 0.125mg recalled by Marlex Pharmaceuticals | Marlex Pharmaceuticals | Packaging Defects | Nationwide |
| Drug | CLASS II | Digoxin Tablets, USP 0.25mg recalled by Marlex Pharmaceuticals | Marlex Pharmaceuticals | Packaging Defects | Nationwide |
| Drug | CLASS II | Digoxin, Tablet, 125 mcg recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |
| Drug | CLASS II | Digoxin, Tablet, 0.125 mg recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |