Dextrose Injection USP 70% Recall: Sterility Concern
DEXTROSE INJECTION USP, 70%, 2000 mL bags, Rx only, Sterile, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7387-50.
What is the FDA recall status?
The FDA record lists this recall as ongoing. FDA enforcement data is not a live recall-lifecycle tracker. Follow the official instructions and check the agency notice or firm for current guidance.
Why was Dextrose Injection USP 70% recalled?
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
What should I do if I have this product?
Follow the firm and FDA instructions for the affected product. Contact the recalling firm for current guidance.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare your product with the product description and available lot, UPC or model codes below from the official FDA record to check whether it is covered by this recall. If an identifier is missing or unclear, check the complete official notice or contact the firm; an incomplete match here does not establish that your product is unaffected.
Full product description
DEXTROSE INJECTION USP, 70%, 2000 mL bags, Rx only, Sterile, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7387-50.
Which lot codes, UPCs or models are affected?
Lot # J5H166, J5H167, Exp Date: 30NOV2026.
- Agency record number
- D-0496-2026
- Product
- DEXTROSE INJECTION USP, 70%, 2000 mL bags, Rx only, Sterile, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7387-50.
- Recalling firm
- B BRAUN MEDICAL INC
- Quantity
- 17,124 bags
- Distribution
- US Nationwide.
- Recall started
- April 2, 2026
- Report date
- April 29, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)