B Braun Dextrose Injection Recall: Risk of Contamination After Foil Removal
B Braun recalls 2000mL dextrose injection bags with potential contamination risk if foil is removed. Affected lots expire Nov 2026. Contact for return instructions.
Lower-risk recall
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
Contact the company
What happened, in plain English
B Braun is recalling dextrose injection bags that could leak from the diaphragm port after the foil is removed, risking contamination. This affects patients receiving IV treatments. The recall is for specific lots with expiration dates through November 2026. Read more at govinfonow.com/recall/31365-b-braun-dextrose-injection-recall-risk-of-contamination-after-foil.
Source Summary by GovInfoNow · govinfonow.com/recall/31365-b-braun-dextrose-injection-recall-risk-of-contamination-after-foil · Updated August 17, 2026 · FDA enforcement record: FDA #D-0496-2026
Cite this page
“B Braun Dextrose Injection Recall: Risk of Contamination After Foil Removal.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/31365-b-braun-dextrose-injection-recall-risk-of-contamination-after-foil. Based on FDA recall #D-0496-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0496-2026%22&limit=1).
Why it’s dangerous
The bags may leak from the diaphragm port once the foil is removed, potentially allowing contamination of the solution. This could lead to infections if the dextrose is used improperly.
Who’s affected
Patients receiving IV dextrose injections through this product are affected. Healthcare providers using the recalled bags for medical treatments are most at risk.
How to tell if you have this one
Check for the product name 'Dextrose Injection USP 70%, 2000 mL bags' with lot numbers J5H166 or J5H167. The expiration date is November 30, 2026.
- Brand
B Braun- Category
Drug
All 4 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
US Nationwide.
| Recall number | Product, codes & lots | Quantity | NDC |
|---|---|---|---|
| D-0495-2026 | Sterile Water for Injection USP, 3000 mL bags, Rx only, Pharmacy Bulk Package, B. Braun Medical Inc., Bethlehem, PA 18018-3524, NDC: 0264-7385-60.; Lot # J5H165, Exp Date: 31 May2028; Lot # J5E237, Exp Date: 30APR2028. | 24,928 bags | 0264-7385-50, 0264-7385-60 |
| D-0496-2026 | DEXTROSE INJECTION USP, 70%, 2000 mL bags, Rx only, Sterile, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7387-50.; Lot # J5H166, J5H167, Exp Date: 30NOV2026. | 17,124 bags | 0264-7387-50 |
| D-0497-2026 | 0.9 % SODIUM CHLORIDE IRRIGATION, USP, 3000 mL bags, Rx only, Sterile, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7388-60.; Lot # J5E226, J5E227, J5E228, J5E229, J5E230, J5E231, J5E232, J5E233, J5E238, J5E239, Exp Date: 30Apr2028, Lot # J5E240, J5E241, J5E242, J5E243, J5E244, J5E245, J5E247, J5E248, Exp Date: 30Apr2028, Lot # J5H151, J5H152, J5H153, J5H154, J5H155, Exp Date: 31 May2028. | 124,244 bags | 0264-7388-50, 0264-7388-60 |
| D-0498-2026 | LACTATED RINGER'S IRRIGATION, 3000 mL bags, Sterile, Ex only, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7389-60.; Lot # J5E234, J5E236, Exp Date: 30APR2028; Lot # J5H158, J5H159, J5H160, J5H161, J5H162, J5H163, J5H174, J5H175, Exp Date: 31MAY2028. | 54,540 bags | 0264-7389-60 |
What to do — step by step
Check Product Details
Verify the lot number and expiration date on the bag to confirm if it's affected.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “US Nationwide.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 27 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0496-2026 (April 2, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0496-2026 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.