Dextrose Injection USP recalled due to sterility assurance concerns
B. Braun Medical Inc. is recalling Dextrose Injection USP 70% in 2000 mL bags nationwide due to lack of assurance of sterility and potential leakage from the diaphragm port after foil removal.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II recall of a sterile injectable drug with potential for microbial contamination (lack of sterility assurance) and product leakage—hazards that could result in serious adverse health consequences including infection in vulnerable patients receiving intravenous therapy.
Plain-English summary
B. Braun Medical Inc. is recalling Dextrose Injection USP, 70%, in 2000 mL bags (NDC: 0264-7387-50) nationwide. The recall affects 17,124 bags from Lots J5H166 and J5H167 with an expiration date of November 30, 2026.
The product is being recalled due to lack of assurance of sterility and potential for leakage from the diaphragm port once the foil is removed. This intravenous medication is distributed nationwide.
Patients and healthcare providers who have this product should not use affected lots. Contact B. Braun Medical Inc. or the FDA for guidance on proper handling and replacement options.
The recalled product
- Product
- DEXTROSE (DEXTROSE)
- Brand
- DEXTROSE
- Manufacturer
- B BRAUN MEDICAL INC
- Category
- Drug — Intravenous Injection
- Hazard
- sterility-assurance
- contamination-risk
- leakage
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot # J5H166
- J5H167
- Exp Date: 30NOV2026.
Distribution
Distributed nationwide across the United States.