FDA Drug recall D-0443-2024
Digoxin Tablets, USP 62.5 mcg (0.0625 mg), 100-count bottles, Rx Only, Manufactured by: Novitium Pharma LLC, 70 Lake Drive, East Windsor, N…
- FDA Drug
- Class III
- terminated
- Published 2024-04-24
On 2024-04-24 the FDA classified a Class III recall of Digoxin Tablets, USP 62.5 mcg (0.0625 mg), 100-count bottles, Rx Only, Manufactured by: Novitium Pharma LLC, 70 Lake Drive, East Windsor, N… by Novitium Pharma, citing failed Impurities/Degradation Specifications.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0443-2024 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2024-03-25 |
| Published | 2024-04-24 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Novitium Pharma |
| Distribution | US |
Product
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
Reason
Failed Impurities/Degradation Specifications
Identifiers
| ndc | 70954-201-10 |
|---|---|
| ndc | 70954-201-20 |
| ndc | 70954-202-10 |
| ndc | 70954-202-20 |
| ndc | 70954-200-10 |
| code_info | Lot M23011A; Exp. 12/2024 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0443-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.