FDA DrugsClass II
5% Dextrose Injection, USP 12.5 g per 250 mL (50 mg per mL) 250 mL in a 250 mL f...
Published: April 15, 2026Recall ID: D-0437-2026Category: drugsCountry: US
Reason for Recall / Hazard
Lack of Assurance of Sterility
Product Description & Identification
5% Dextrose Injection, USP 12.5 g per 250 mL (50 mg per mL) 250 mL in a 250 mL freeflex bag, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Use NDC: 65219-458-05, Unit of Sale NDC Number: 65219-458-30.
Additional Source Details
| Field | Value |
|---|---|
| City | Lake Zurich |
| State | IL |
| Openfda › Unii | LX22YL083G |
| Openfda › Route | INTRAVENOUS |
| Openfda › Rxcui › 1 | 1795607 |
| Openfda › Rxcui › 2 | 1795609 |
| Openfda › Rxcui › 3 | 1795610 |
| Openfda › Rxcui › 4 | 1795612 |
| Openfda › Rxcui › 5 | 1795616 |
| Openfda › Spl id | efc3b0c9-518a-47db-bb3e-ebdfd4646e9b |
| Openfda › Brand name | DEXTROSE |
| Openfda › Spl set id | 576a22d8-5f2f-497e-80ad-1842ca74bb53 |
| Openfda › Package ndc › 1 | 65219-456-05 |
| Openfda › Package ndc › 2 | 65219-456-60 |
| Openfda › Package ndc › 3 | 65219-464-05 |
| Openfda › Package ndc › 4 | 65219-464-50 |
| Openfda › Package ndc › 5 | 65219-458-05 |
| Openfda › Package ndc › 6 | 65219-458-30 |
| Openfda › Package ndc › 7 | 65219-460-05 |
| Openfda › Package ndc › 8 | 65219-460-20 |
| Openfda › Package ndc › 9 | 65219-462-05 |
| Openfda › Package ndc › 10 | 65219-462-10 |
| Openfda › Product ndc › 1 | 65219-456 |
| Openfda › Product ndc › 2 | 65219-464 |
| Openfda › Product ndc › 3 | 65219-458 |
| Openfda › Product ndc › 4 | 65219-460 |
| Openfda › Product ndc › 5 | 65219-462 |
| Openfda › Generic name | DEXTROSE MONOHYDRATE |
| Openfda › Product type | HUMAN PRESCRIPTION DRUG |
| Openfda › Substance name | DEXTROSE MONOHYDRATE |
| Openfda › Manufacturer name | FRESENIUS KABI USA, LLC |
| Openfda › Application number | ANDA207449 |
| Openfda › Is original packager | true |
| Event id | 98581 |
| Address 1 | 3 Corporate Dr |
| Code info | Batch# 6402165, Exp Date: 05/30/2028. |
| Postal code | 60047-8930 |
| Report date | 20260415 |
| Product type | Drugs |
| Reason for recall | Lack of Assurance of Sterility |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260311 |
| Initial firm notification | Letter |
| Center classification date | 20260403 |
Overview
- Recalling FirmFresenius Kabi USA, LLC
- StatusOngoing
- Risk LevelClass II
- DistributionUS Nationwide , Alaska, and Puerto Rico.