Abelcet — Class II drug recall D-0327-2023
Terminated recall by Leadiant Biosciences, Inc., reported 2023-02-22, distributed nationwide. Lack of assurance of sterility: Medial fill with presence of Cupriavidus pauculus.
| Recall number | D-0327-2023 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Leadiant Biosciences, Inc., Gaithersburg, MD, United States |
| Recall initiated | 2023-02-03 |
| Classified | 2023-02-15 |
| Reported by FDA | 2023-02-22 |
| Terminated | 2024-09-30 |
| Distributed | Nationwide (US) |
| Quantity | 31,879 vials |
| Reason classes | sterility |
| NDC | 57665-0101-41 |
| Lot numbers | 1203A |
| Expiration dates | 2024-05-11 |
Product
Abelcet (Amphotericin B Lipid Complex) Injection, 5 mg/mL, 100 mg vial, Rx only, Manufactured by Exelead, Inc., Indianapolis, IN 46268; Distributed by Leadiant Biosciences, Inc., Gaithersburg, MD 20878, NDC 57665-101-41
Reason for recall
Lack of assurance of sterility: Medial fill with presence of Cupriavidus pauculus.
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-0327-2023. 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.