B Braun recalls 500mL 0.9% Sodium Chloride Injection with pinholes in packaging that may cause leaks. Affected lots expire 2/28/2027. Stop using immediately to avoid contamination risks.
“B Braun 500mL Sodium Chloride Injection Recall: Pinhole Leaks Risk Contamination.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/32026-b-braun-500ml-sodium-chloride-injection-recall-pinhole-leaks-risk. Based on FDA recall #D-0491-2025 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0491-2025%22&limit=1).
B Braun Medical Inc. is voluntarily recalling 0.9% Sodium Chloride Injection USP, 500 mL, due to a lack of sterility assurance caused by pinholes in finger boxes. The Food and Drug Administration announced the Class II recall on June 16, 2025.
How to tell if you have it
Brand: B Braun
Product: 0.9% Sodium Chloride Injection USP, 500 mL
Packaging: 500 mL excel containers, 24 per case
NDC: 0264-7800-10
Lot Codes: J4L260, J4L261, J4L270, J4L271, J4L280
Expiration Date: 2/28/2027
Distribution: USA Nationwide
The hazard
The recall addresses a lack of assurance of sterility resulting from pinholes within the finger boxes used during the Form Fill Seal process, which can cause leaks. 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 October 15, 2013. Recent brand recalls include a August 19, 2026, recall for particulate matter hazards in 100mL Sodium Chloride Injection and a August 12, 2026, recall for Lactated Ringer's Injection involving particulate matter. Other recent recalls of similar products include an August 17, 2026, Baxter recall for fiberglass particulates in 0.9% Sodium Chloride Injection and a March 11, 2026, Fresenius Kabi recall for lack of sterility assurance in 1000mL Sodium Chloride Injection.
How to tell if you have this one
Check for lot numbers J4L260, J4L261, J4L270, J4L271, J4L280 on the packaging. The product is a 500mL 0.9% Sodium Chloride Injection sold in 24-per-case packaging with an expiration date of 2/28/2027.
Brand
B Braun
Category
Drug
Based on the official FDA remedy
What to do — step by step
Stop Using Immediately
Discard the recalled 500mL 0.9% Sodium Chloride Injection with lot numbers J4L260, J4L261, J4L270, J4L271, or J4L280.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “USA 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 16 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
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-0491-2025 (June 16, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0491-2025 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.