Why it was recalled
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
Product description
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 numbers, UPCs & expiration codes
Lot # J5H165, Exp Date: 31 May2028; Lot # J5E237, Exp Date: 30APR2028.
Where it was sold
US Nationwide.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0495-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Apr 2, 2026
- FDA report date
- Apr 29, 2026
- Quantity
- 24,928 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- B BRAUN MEDICAL INC
Original FDA data
Every field from FDA enforcement report D-0495-2026, exactly as published.
Show all FDA fields
- City
- Allentown
- State
- PA
- Status
- Ongoing
- Country
- United States
- Event ID
- 98693
- Address
- 861 Marcon Blvd
- Code information
- Lot # J5H165, Exp Date: 31 May2028; Lot # J5E237, Exp Date: 30APR2028.
- Postal code
- 18109-9577
- Report date
- Apr 29, 2026
- Product type
- Drugs
- Recall number
- D-0495-2026
- Classification
- Class II
- Recalling firm
- B BRAUN MEDICAL INC
- Product quantity
- 24,928 bags
- Reason for recall
- Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- US Nationwide.
- Recall initiation date
- Apr 2, 2026
- Initial firm notification
- Letter
- Center classification date
- Apr 28, 2026