Class IDrug
0.9% Sodium Chloride Injection recall
Summary
B BRAUN MEDICAL INC is recalling 0.9% Sodium Chloride Injection (drug). According to the FDA report, the reason is: Presence of Particulate Matter: particulate matter identified as iron oxide, inorganic material, cellulose cotton fiber or polystyrene. The FDA rated this a Class I: most serious: there is a reasonable chance the product could cause serious health problems or death. Recall status: Ongoing.
Understanding this recall
What happened
B. Braun is recalling 0.9% Sodium Chloride Injection (100 mL partial fill in 150 mL PAB containers) because particles were found, including iron oxide, cellulose cotton fiber and polystyrene.
Why it matters
Medicines given by injection or IV go straight into the bloodstream, so they must be free of visible and sub-visible particles. Particles such as glass, metal or plastic in an injectable can, in principle, block small blood vessels or cause irritation, inflammation or clots. That risk is why the FDA treats particulate matter in injectables seriously.
Who should pay attention
Hospital, clinic and pharmacy staff who use these saline containers, often used to mix IV medications.
Distribution in the FDA report: Nationwide within the United States
How to check your product
Check the lot number and expiration date on the container.
Codes listed by the FDA: Lot #: J6B435, J6B444, J6B457, Exp Date: 30APR2027.
Based only on the FDA enforcement record plus general public-health background on this type of hazard. Not medical advice; if you have symptoms or concerns, contact a doctor or pharmacist.
Details from the FDA report
- Product
- 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.
- Reason
- Presence of Particulate Matter: particulate matter identified as iron oxide, inorganic material, cellulose cotton fiber or polystyrene
- Lot / code info
- Lot #: J6B435, J6B444, J6B457, Exp Date: 30APR2027.
- Quantity
- 201,472 total container
- Distribution
- Nationwide within the United States
- Recalling company
- B BRAUN MEDICAL INC, Allentown, PA United States
- Recall started
- August 19, 2026
- FDA report date
- September 16, 2026
- Classification
- Class I: Most serious: there is a reasonable chance the product could cause serious health problems or death.
- Voluntary / mandated
- Voluntary: Firm initiated
- Status
- Ongoing
- Recall number
- D-0869-2026
What to do
- Check whether you have this product, and compare the lot numbers, codes, or dates on your package with the codes listed above.
- If it matches, stop using it and keep it away from children and pets.
- Contact the recalling company (B BRAUN MEDICAL INC) or the store where you bought it about returns or refunds.
- Do not stop a prescribed medication without first talking to your pharmacist or doctor; they can help find a safe replacement.
- If you think the product made you or someone else sick, contact a doctor or pharmacist. In an emergency call 911.
- You can report problems to the FDA via MedWatch.