← FDA ENFORCEMENT
D-0585-2025Class II

B BRAUN MEDICAL INC

Recalling firm
B BRAUN MEDICAL INC
Product type
Drug
Status
Ongoing
Report date
2025-08-20
Distribution
Nationwide in the US
Firm state
PA
Product quantity
74,088 containers
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites.

Product description

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.

Code / lot info

Lot #: J5C802, J5C917, J5C918, Exp. 08/31/2027

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See all Environmental Monitoring recalls →

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.