FDA Drug recall D-0435-2026
5% Dextrose Injection, USP 2.5 g per 50 mL (50 mg per mL) 50 mL in a 100 mL freeflex bag, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit…
- FDA Drug
- Class II
- ongoing
- Published 2026-04-15
On 2026-04-15 the FDA classified a Class II recall of 5% Dextrose Injection, USP 2.5 g per 50 mL (50 mg per mL) 50 mL in a 100 mL freeflex bag, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit… by Fresenius Kabi Usa, citing lack of Assurance of Sterility.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0435-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-03-11 |
| Published | 2026-04-15 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Fresenius Kabi Usa |
| Distribution | US |
Product
5% Dextrose Injection, USP 2.5 g per 50 mL (50 mg per mL) 50 mL in a 100 mL freeflex bag, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Use NDC: 65219-456-05, Unit of Sale NDC Number: 65219-456-60.
Reason
Lack of Assurance of Sterility
Identifiers
| ndc | 65219-456-05 |
|---|---|
| ndc | 65219-456-60 |
| ndc | 65219-464-05 |
| ndc | 65219-464-50 |
| ndc | 65219-458-05 |
| ndc | 65219-458-30 |
| ndc | 65219-460-05 |
| ndc | 65219-460-20 |
| ndc | 65219-462-05 |
| ndc | 65219-462-10 |
| code_info | Batch# 6402296, Exp Date: 07/31/2026. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0435-2026%22
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