B Braun Medical Inc drug recall: Lactated Ringers's Injection USP
Key facts
- Agency
- U.S. Food and Drug Administration (FDA)
- Program
- Drugs
- Classification
- Class I
- Status
- Ongoing
- Event ID
- 97433
- Recall initiated
- Aug 18, 2025
- Classified by FDA
- Sep 10, 2025
- Posted in Enforcement Report
- Sep 10, 2025
- 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
- 2
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
Presence of Particulate Matter.
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 18, 2025. FDA classified it 23 days later, on Sep 10, 2025. This recall event covers 2 separate products, each with its own FDA recall number. Distribution reported by FDA: U.S.A. Nationwide B BRAUN MEDICAL INC has 91 recalls in our records.
Recalled products (2)
D-0627-2025 Class I Ongoing
Lactated Ringers's Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-7750-07
Codes / lots: Lot #: J4S807, Exp 5/31/2027
Quantity: 46,032 containers
D-0628-2025 Class I Ongoing
0.9% Sodium Chloride Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-7800-09
Codes / lots: Lot #: V3K770, Exp 1/31/2026
Quantity: 47,148 containers
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 97433
- 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.