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Drug FDA Class II Ongoing Contamination / non-sterility

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.

B BRAUN MEDICAL INC Published Aug 20, 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; potential for fluid leakage at one of the weld sites.

Hazards

Lack of Sterility Assurance · primaryFluid Leakage at Weld Site

Affected products (1)

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.

LACTATED RINGERS · 74,088 containers

NDC: 0264-7750, 0264-7750-00, 0264-7750-10, 0264-7750-20
Code info: Lot #: J5C802, J5C917, J5C918, Exp. 08/31/2027

Affected areas

Nationwide

Timeline

  1. Initiated
    Aug 4, 2025
  2. Published
    Aug 20, 2025
Recall number
D-0585-2025
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.