FDA Recall D-0435-2026
Fresenius Kabi USA, LLC · Lake Zurich, IL
Class II Ongoing 64 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
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 for recall
Lack of Assurance of Sterility
Recall record
- Recall number
D-0435-2026- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- US Nationwide , Alaska, and Puerto Rico.
- Recall initiated
- 2026-03-11
- Classified by FDA Center
- 2026-04-03
- FDA published
- 2026-04-15
- Recalling firm
- Fresenius Kabi USA, LLC
- Firm location
- Lake Zurich, IL
Drug identification
- Brand name(s)
- DEXTROSE
- Generic name(s)
- DEXTROSE MONOHYDRATE
- Manufacturer(s)
- FRESENIUS KABI USA, LLC
- NDC(s)
65219-456, 65219-464, 65219-458, 65219-460, 65219-462- Route(s)
- INTRAVENOUS
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.