FDA Drug recall D-0389-2024
Digoxin Tablets, USP 125mcg, (0.125 mg), 1000-count bottle, Rx Only, Manufactured by: Novitium Pharma LLC., 70 Lake Drive, East Windsor, Ne…
- FDA Drug
- Class III
- terminated
- Published 2024-03-27
On 2024-03-27 the FDA classified a Class III recall of Digoxin Tablets, USP 125mcg, (0.125 mg), 1000-count bottle, Rx Only, Manufactured by: Novitium Pharma LLC., 70 Lake Drive, East Windsor, Ne… by Novitium Pharma, citing cross Contamination with Other Products:(mycophenolate mofetil).
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0389-2024 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2024-03-04 |
| Published | 2024-03-27 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Novitium Pharma |
| Distribution | US |
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
Reason
Cross Contamination with Other Products:(mycophenolate mofetil).
Identifiers
| ndc | 70954-201-10 |
|---|---|
| ndc | 70954-201-20 |
| ndc | 70954-202-10 |
| ndc | 70954-202-20 |
| ndc | 70954-200-10 |
| code_info | Lot #: M23172A, Exp 01/31/2025 |
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-0389-2024%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.