Why it was recalled
Presence of Particulate Matter: particulate matter identified as iron oxide, inorganic material, cellulose cotton fiber or polystyrene
Product description
0.9% Sodium Chloride Injection, USP, 100 mL Partial Fill in 150 mL PAB Container, Sterile, Rx only, B. Braun Medical Inc., Bethlehem, PA 18018 USA, NDC 0264-1800-32.
Lot numbers, UPCs & expiration codes
Lot #: J6B435, J6B444, J6B457, Exp Date: 30APR2027.
Where it was sold
Nationwide within the United States
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-0869-2026
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- Aug 19, 2026
- FDA report date
- Sep 16, 2026
- Quantity
- 201,472 total container
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- B BRAUN MEDICAL INC
Original FDA data
Every field from FDA enforcement report D-0869-2026, exactly as published.
Show all FDA fields
- City
- Allentown
- State
- PA
- Status
- Ongoing
- Country
- United States
- Event ID
- 99703
- Address
- 861 Marcon Blvd
- Code information
- Lot #: J6B435, J6B444, J6B457, Exp Date: 30APR2027.
- Postal code
- 18109-9577
- Report date
- Sep 16, 2026
- Product type
- Drugs
- Recall number
- D-0869-2026
- Classification
- Class I
- Recalling firm
- B BRAUN MEDICAL INC
- Product quantity
- 201,472 total container
- Reason for recall
- Presence of Particulate Matter: particulate matter identified as iron oxide, inorganic material, cellulose cotton fiber or polystyrene
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 0.9% Sodium Chloride Injection, USP, 100 mL Partial Fill in 150 mL PAB Container, Sterile, Rx only, B. Braun Medical Inc., Bethlehem, PA 18018 USA, NDC 0264-1800-32.
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Aug 19, 2026
- Initial firm notification
- Letter
- Center classification date
- Sep 22, 2026