Digoxin Tablets — Class III drug recall D-0443-2024
Terminated recall by Novitium Pharma LLC, reported 2024-04-24, distributed nationwide. Failed Impurities/Degradation Specifications
| Recall number | D-0443-2024 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Novitium Pharma LLC, East Windsor, NJ, United States |
| Recall initiated | 2024-03-25 |
| Classified | 2024-04-13 |
| Reported by FDA | 2024-04-24 |
| Terminated | 2024-07-16 |
| Distributed | Nationwide (US) |
| Quantity | 1,003 bottles |
| Reason classes | specification failure |
| NDC | 70954-0200, 70954-0200-10, 70954-0201, 70954-0201-10, 70954-0201-20, 70954-0202, 70954-0202-10, 70954-0202-20 |
| Lot numbers | M23011A |
| Expiration dates | 2024-12 |
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 for recall
Failed Impurities/Degradation Specifications
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0443-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.