DEXTROSE INJECTION USP, 70%, 2000 mL bags, Rx only,… was recalled on April 2, 2026 in cooperation with the U.S. Food and Drug Administration because lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed..
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.
Units affected: 17,124 bags
Where it was sold: US Nationwide.
Compare the codes above against the label on your product — usually on the bottom, the back panel, or the packaging. If your unit isn't listed, it is not part of this recall.
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
Class II means the product might cause a temporary or medically reversible health problem; the chance of serious harm is remote.
Stop using the product. Return it to the place of purchase for a refund, or dispose of it. Contact the recalling firm with questions.
Contact: Recalling firm: B BRAUN MEDICAL INC
Not sure what you're entitled to? Read our guide: what to do if your product is recalled.
Always confirm details on the official notice from the U.S. Food and Drug Administration before acting.
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Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU).
Potential foreign object contamination: rubber pieces
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