Lower risk Drug recall · FDA · Published November 25, 2022

B. Braun Medical 0.9% Sodium Chloride Injection Recall: Leakage Risk

B. Braun Medical recalls 1000mL single-dose 0.9% Sodium Chloride Injection (NDC 0264-5802-00) due to potential leakage. This could compromise sterility. Contact for details.

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

🇺🇸 FDA recall #D-0076-2023Drug B. Braun Medical ›

Lower-risk recall

Lack of sterility assurance: Bags have the potential to leak.

Take action

Contact the company

Recalling firmB. Braun Medical, Inc.901 Marcon Blvd · Allentown, PA 18109-9512

✎ GovInfoNow plain-language explainer

B. Braun Medical is recalling 1000mL single-dose 0.9% Sodium Chloride Injection bottles because they may leak, risking contamination. This affects prescription-only medical use. Read more at govinfonow.com/recall/34214-b-braun-medical-0-9-sodium-chloride-injection-recall-leakage.

Source Summary by GovInfoNow · govinfonow.com/recall/34214-b-braun-medical-0-9-sodium-chloride-injection-recall-leakage · Updated August 18, 2026 · FDA enforcement record: FDA #D-0076-2023

Cite this page

“B. Braun Medical 0.9% Sodium Chloride Injection Recall: Leakage Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/34214-b-braun-medical-0-9-sodium-chloride-injection-recall-leakage. Based on FDA recall #D-0076-2023 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0076-2023%22&limit=1).

B. Braun Medical Inc. voluntarily recalled 0.9% Sodium Chloride Injection USP 1000 mL single-dose containers due to a lack of sterility assurance because bags have the potential to leak, according to the FDA on Nov. 25, 2022.

How to tell if you have it

Brand: B. Braun Medical
Product: 0.9% Sodium Chloride Injection USP 1000 mL Single-dose container Rx only
NDC: 0264-5802-00
Lot: 0061832446
Expiration: 31 Oct 2024
Distribution: FL, NJ, PA
Units affected: 756 bags

The hazard

The recall addresses a lack of sterility assurance because the bags have the potential to leak. The FDA classified this as a Class II recall.

Context

GovInfoNow's records show B Braun Medical Inc has 66 other recalls on record since Oct. 15, 2013. Other recent recalls of similar products include Fresenius Kabi 1000mL Sodium Chloride Injection Recall (March 11, 2026), Fresenius Kabi 500mL Sodium Chloride Injection Recall (March 11, 2026) and Fresenius Kabi 0.9% Sodium Chloride Injection Recall (March 11, 2026).

How to tell if you have this one

Check for the label: 0.9% Sodium Chloride Injection USP 1000 mL Single-dose container, NDC 0264-5802-00. The lot number 0061832446 expires October 31, 2024.

Brand
B. Braun Medical
Category
Drug

Based on the official FDA remedy

What to do — step by step

Check Product Label
Look for the NDC code 0264-5802-00 and lot number 0061832446 on the bottle.

Where it went and when

Where it was distributed

Distributed in 3 states.

FDA distribution: “FL, NJ, PA” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Florida, New Jersey, Pennsylvania.

Recall timeline

FDA terminated this recall 21 months after the firm started it.

Nov 25, 2022Firm started the recall
Dec 5, 2022FDA classified it Class II
Dec 14, 2022Published in FDA’s Enforcement Report
Aug 23, 2024FDA terminated the recall

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

Similar recalls

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Keep exploring

Link to this recall

<a href="https://govinfonow.com/recall/34214-b-braun-medical-0-9-sodium-chloride-injection-recall-leakage">B. Braun Medical 0.9% Sodium Chloride Injection Recall: Leakage Risk (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-0076-2023 (November 25, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0076-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 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.