Lower risk Drug recall · FDA · Published August 4, 2025

B Braun Medical 1000mL Sodium Chloride Injection Recall: Risk of Contamination

B Braun Medical recalls 1000mL sterile 0.9% Sodium Chloride Injection due to potential contamination from fluid leakage at weld sites. Affected lots: J5C919 (expiring 08/31/2027).

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0586-2025Drug B Braun Medical ›

B Braun Medical — official photo 1 — Official FDA recall photos · click to enlarge

Lower-risk recall

Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites.

Take action

Contact the company

Recalling firmB BRAUN MEDICAL INC861 Marcon Blvd · Allentown, PA 18109-9577

✎ GovInfoNow plain-language explainer

B Braun Medical is recalling 1000mL sterile 0.9% Sodium Chloride Injection because it may leak at weld sites, risking contamination. This could lead to infections if used improperly. Read more at govinfonow.com/recall/31888-b-braun-medical-1000ml-sodium-chloride-injection-recall-risk-of.

Source Summary by GovInfoNow · govinfonow.com/recall/31888-b-braun-medical-1000ml-sodium-chloride-injection-recall-risk-of · Updated August 17, 2026 · FDA enforcement record: FDA #D-0586-2025

Cite this page

“B Braun Medical 1000mL Sodium Chloride Injection Recall: Risk of Contamination.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/31888-b-braun-medical-1000ml-sodium-chloride-injection-recall-risk-of. Based on FDA recall #D-0586-2025 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0586-2025%22&limit=1).

B Braun Medical Inc. voluntarily recalled 0.9% Sodium Chloride Injection USP, L 8000, 1000mL Excel Container nationwide due to a lack of sterility assurance and potential fluid leakage, the FDA said on Aug. 4, 2025.

How to tell if you have it

Brand: B Braun Medical
Product: 0.9% Sodium Chloride Injection USP, L 8000, 1000mL Excel Container
NDC: 0264-7800-00
Lot #: J5C919
Expiration: 08/31/2027

The hazard

The recall addresses a lack of assurance of sterility and the potential for fluid leakage at one of the weld sites.

Context

GovInfoNow's records show B Braun Medical Inc. has 66 other recalls on record since Oct. 15, 2013. Recent recalls include a Aug. 19, 2026 particulate matter hazard in 100mL Sodium Chloride Injection and an Aug. 12, 2026 particulate matter issue in Lactated Ringer's Injection. Other recent recalls of similar products include Fresenius Kabi 1000mL Sodium Chloride Injection Recall (March 11, 2026), Fresenius Kabi 0.9% Sodium Chloride Injection Recall (March 11, 2026), and Huons Co. 10mL Sodium Chloride Injection Recall (April 2, 2026).

How to tell if you have this one

Check for the lot number J5C919 on the container. The product is a 1000mL sterile 0.9% Sodium Chloride Injection labeled as Rx Only, with an expiration date of 08/31/2027.

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 II
Status
Ongoing
Distribution
Nationwide in the US

Recall number	Product, codes & lots	Quantity	NDC
D-0585-2025	Lactated Ringer's Injection USP, L 7500, 1000mL Excel Container, Rx Only, Sterile, nonpyrogenic, single dose container, B. Braun Medical Inc., Bethlehem, PA 18018, NDC 0264-7750-00.; Lot #: J5C802, J5C917, J5C918, Exp. 08/31/2027	74,088 containers	0264-7750-00, 0264-7750-10, 0264-7750-20
D-0586-2025	0.9% Sodium Chloride Injection USP, L 8000, 1000mL Excel Container, Rx Only, Sterile, nonpyrogenic, single dose container, B. Braun Medical Inc., Bethlehem, PA 18018, NDC 0264-7800-00.; Lot #: J5C919, Exp. 08/31/2027	23,100 containers	0264-7800-00, 0264-7800-10, 0264-7800-20, 0264-7802-00, 0264-7802-10

Based on the official FDA remedy

What to do — step by step

Check Product Lot Number
Look for the lot number J5C919 on the container to confirm if it's affected.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Nationwide in the US” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 16 days after the firm started it.

Aug 4, 2025Firm started the recall
Aug 14, 2025FDA classified it Class II
Aug 20, 2025Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/31888-b-braun-medical-1000ml-sodium-chloride-injection-recall-risk-of">B Braun Medical 1000mL Sodium Chloride Injection Recall: Risk of Contamination (GovInfoNow)</a>

Where this comes from

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-0586-2025 (August 4, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0586-2025 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.