Why it was recalled
Presence of Particulate Matter.
Product description
0.9% Sodium Chloride Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-7800-09
Lot numbers, UPCs & expiration codes
Lot #: V3K770, Exp 1/31/2026
Where it was sold
U.S.A. 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-0628-2025
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- Aug 18, 2025
- FDA report date
- Sep 10, 2025
- Quantity
- 47,148 containers
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- B BRAUN MEDICAL INC
Original FDA data
Every field from FDA enforcement report D-0628-2025, exactly as published.
Show all FDA fields
- City
- Allentown
- State
- PA
- Status
- Ongoing
- Country
- United States
- Event ID
- 97433
- Address
- 861 Marcon Blvd
- Code information
- Lot #: V3K770, Exp 1/31/2026
- Postal code
- 18109-9577
- Report date
- Sep 10, 2025
- Product type
- Drugs
- Recall number
- D-0628-2025
- Classification
- Class I
- Recalling firm
- B BRAUN MEDICAL INC
- Product quantity
- 47,148 containers
- Reason for recall
- Presence of Particulate Matter.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 0.9% Sodium Chloride Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-7800-09
- Distribution pattern
- U.S.A. Nationwide
- Recall initiation date
- Aug 18, 2025
- Initial firm notification
- Letter
- Center classification date
- Sep 10, 2025