CLASS II ONGOING Drug recall · Reported 29 Apr 2026 · FDA Enforcement Report
Dextrose Injection recalled by B Braun Medical
B Braun Medical is recalling Dextrose Injection USP, 70%, distributed nationwide in the US. The recall was initiated on 2 Apr 2026 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0496-2026
- FDA event ID
- 98693
- Recalling firm
- B Braun Medical, Allentown, PA
- Brand
- Dextrose
- Manufacturer
- B. Braun Medical Inc.
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 2 Apr 2026
- FDA classified
- 28 Apr 2026
- Reported
- 29 Apr 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 2 Apr 2026 | Recall initiated by company | |
| 28 Apr 2026 | Classified by FDA | +26 days |
| 29 Apr 2026 | Published in enforcement report | +1 day |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
DEXTROSE INJECTION USP, 70%, 2000 mL bags, Rx only, Sterile, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7387-50.
Where it was distributed
US Nationwide.
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
Which lots are affected?
Lot # J5H166, J5H167, Exp Date: 30NOV2026.
Where was it sold?
US Nationwide.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 98693| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Lactated Ringer's Irrigation, Sterile, Ex only recalledLactated Ringers Irrigation | B Braun Medical | Sterility | Nationwide | |
| CLASS II | 0.9 % Sodium Chloride Irrigation recalled by B Braun MedicalSodium Chloride For Irrigation | B Braun Medical | Sterility | Nationwide | |
| CLASS II | Sterile Water for Injection recalled by B Braun MedicalSterile Water | B Braun Medical | Sterility | Nationwide |
More recalls from B Braun Medical
All 447| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | 0.9% Sodium Chloride Injection, USP Partial Fill recalledSodium Chloride | B Braun Medical | Particulate Matter | Nationwide |
| Device | CLASS II | Extension Set Discofix Four Way Stopcock recalled by B Braun Medical | B Braun Medical | Other | Nationwide |
| Drug | CLASS I | Lactated Ringer's Injection USP Excel container recalledLactated Ringers | B Braun Medical | Particulate Matter | Nationwide |
| Device | CLASS I | Design Options Spinal Tray Spinal Needle Anesthesia recalled | B Braun Medical | Processing Deviation | Nationwide |
| Device | CLASS II | Sesk Upmc Double Catheter Tray recalled by B Braun Medical | B Braun Medical | Device Malfunction | Nationwide |
Other Dextrose recalls
All 44| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Dextrose Injection, USP, 70 % recalled by Baxter Healthcare | Baxter Healthcare | Particulate Matter | Nationwide |
| Drug | CLASS II | 5% Dextrose Injection, USP per (50 mg per mL) in a freeflex recalledDextrose | Fresenius Kabi USA | Sterility | Nationwide |
| Drug | CLASS II | 5% Dextrose Injection, USP per (50 mg per mL) in a freeflex recalledDextrose | Fresenius Kabi USA | Sterility | Nationwide |
| Drug | CLASS II | 5% Dextrose Injection, USP per (50 mg per mL) in a freeflex recalledDextrose | Fresenius Kabi USA | Sterility | Nationwide |
| Drug | CLASS II | Delflex Peritoneal Dialysis Solution With Low Magnesium recalledDelflex | Fresenius Medical Care Holdings | Packaging Defects | Nationwide |