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Drug FDA Class II Ongoing Contamination / non-sterility

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.

B BRAUN MEDICAL INC Published Jul 2, 2025

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact B BRAUN MEDICAL INC or your place of purchase with questions, and see the source record below for full details.
Reason for recall

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

Hazards

Lack of sterility assurance due to container pinholes · primary

Affected products (1)

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.

SODIUM CHLORIDE · 187,656 containers

NDC: 0264-7800, 0264-7802, 0264-7800-00, 0264-7800-10, 0264-7800-20, 0264-7802-00, 0264-7802-10
Code info: Lot #: J4L260, J4L261, J4L270, J4L271, J4L280, Exp 2/28/2027

Affected areas

Nationwide

Timeline

  1. Initiated
    Jun 16, 2025
  2. Published
    Jul 2, 2025
Recall number
D-0491-2025
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.