Use cautionDrug recall · FDA · Published August 18, 2025
B. Braun Medical 1000mL IV Fluid Recall: Particulate Matter Hazard
B. Braun Medical recalls 1000mL 0.9% Sodium Chloride Injection due to particulate matter risk. This IV fluid, sold Rx only, may cause serious injury if particles enter bloodstream.
“B. Braun Medical 1000mL IV Fluid Recall: Particulate Matter Hazard.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/31866-b-braun-medical-1000ml-iv-fluid-recall-particulate-matter-hazard. Based on FDA recall #D-0628-2025 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0628-2025%22&limit=1).
B. Braun Medical Inc., Bethlehem, PA, is voluntarily recalling 0.9% Sodium Chloride Injection USP in 1000 mL containers due to the presence of particulate matter, according to the Food and Drug Administration (FDA). The FDA announced the Class I recall on August 18, 2025.
How to tell if you have it
Brand: B. Braun Medical
Product: 0.9% Sodium Chloride Injection USP
NDC: 0264-7800-09
Lot #: V3K770
Expiration Date: 1/31/2026
Quantity: 47,148 containers
The hazard
The recall addresses the presence of particulate matter in the injection solution. The FDA classified this as a Class I recall, indicating a high risk of adverse health consequences.
Context
GovInfoNow's records show B BRAUN MEDICAL INC has 66 other recalls on record since October 15, 2013. Recent similar recalls include the August 19, 2026 recall of B. Braun Medical 100mL Sodium Chloride Injection and the August 12, 2026 recall of B. Braun Medical Lactated Ringer's Injection, both citing particulate matter hazards. Other recent recalls of similar products include the March 24, 2026 GE Healthcare Omnipaque 300 mg/mL Injection Recall and the July 24, 2026 American Regent Atropine Sulfate Injection Recall.
How to tell if you have this one
Check for the product name '0.9% Sodium Chloride Injection USP, 1000 mL container' sold by prescription. Look for lot number V3K770 with expiration date 1/31/2026.
Brand
B. Braun Medical
Category
Drug
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class I
Status
Ongoing
Distribution
U.S.A. Nationwide
Recall number
Product, codes & lots
Quantity
NDC
D-0627-2025
Lactated Ringers's Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-7750-07; Lot #: J4S807, Exp 5/31/2027
46,032 containers
0264-7750-07
D-0628-2025
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 #: V3K770, Exp 1/31/2026
47,148 containers
0264-7800-09
Based on the official FDA remedy
What to do — step by step
Check Product Details
Verify the product name, lot number (V3K770), and expiration date (1/31/2026) to confirm if it's recalled.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “U.S.A. Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 23 days after the firm started it.
1Firm started the recall
2FDA classified it Class I
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #D-0628-2025 (August 18, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0628-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.