B Braun Medical Inc drug recall: 0.9% Sodium Chloride Injection
Key facts
- Agency
- U.S. Food and Drug Administration (FDA)
- Program
- Drugs
- Classification
- Class I
- Status
- Ongoing
- Event ID
- 99703
- Recall initiated
- Aug 19, 2026
- Classified by FDA
- Sep 22, 2026
- Posted in Enforcement Report
- Sep 16, 2026
- Recalling firm
- B BRAUN MEDICAL INC
- Firm location
- Allentown, PA, United States
- Initiated by
- Voluntary: Firm initiated
- Firm notified customers by
- Letter
- Products in this event
- 1
What to do
Compare the product, lot or serial numbers below with what you have. If you use a prescription drug or medical device in this recall, talk to your pharmacist or health care provider before you stop using it, and follow the firm's instructions.
Reason for recall
Presence of Particulate Matter: particulate matter identified as iron oxide, inorganic material, cellulose cotton fiber or polystyrene
What the classification means
- Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.
About this recall
The firm started this recall on Aug 19, 2026. FDA classified it 34 days later, on Sep 22, 2026. Distribution reported by FDA: Nationwide within the United States B BRAUN MEDICAL INC has 91 recalls in our records.
Recalled products (1)
D-0869-2026 Class I Ongoing
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.
Codes / lots: Lot #: J6B435, J6B444, J6B457, Exp Date: 30APR2027.
Quantity: 201,472 total container
Source and freshness
- Source
- U.S. Food and Drug Administration (FDA) Enforcement Report, via the openFDA drug enforcement dataset
- Official notice
- FDA Enforcement Report, event 99703
- Raw record
- openFDA API (JSON)
- Dataset last updated by FDA
- Nov 3, 2026
- Imported by RecallRadar
- Nov 4, 2026
Enforcement Report entries describe recalls FDA has classified. They are not always the same as a company press release. If something here differs from FDA's record, FDA's record is correct — please tell us.