Reported Jul 2, 2025 · Ongoing

0.9% Sodium Chloride Injection USP, 500 mL, packaged in 500 mL excel containers and further packaged 24 per case, Rx…

B Braun Medical Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: B BRAUN MEDICAL INC · 861 Marcon Blvd · Allentown, PA · 18109-9577

Is this the product you have?

  • 0.9% Sodium Chloride Injection USP, 500 mL, packaged in 500 mL excel containers and further packaged 24 per case, Rx only, B.Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC 0264-7800-10.
Lot codes and dates
    • Lot #: J4L260
    • J4L261
    • J4L270
    • J4L271
    • J4L280
    • Exp 2/28/2027
Amount recalled
187,656 containers

Where it was sold

  • Nationwide

Why it was recalled

Lack of assurance of sterility: pinholes, within the finger boxes used during Form Fill Seal process resulting in leaks.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Data as of Sep 19, 8:08 PM UTC

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