← FDA ENFORCEMENT
D-0496-2026Class II

B BRAUN MEDICAL INC

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
B BRAUN MEDICAL INC
Product type
Drug
Status
Ongoing
Report date
2026-04-29
Distribution
US Nationwide.
Firm state
PA
Product quantity
17,124 bags
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.

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.

Code / lot info

Lot # J5H166, J5H167, Exp Date: 30NOV2026.

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →