Sterile Water for Injection USP, 3000 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..
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.
Units affected: 24,928 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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cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
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