Lactated Ringers Injection, Solution
FDA Recall NDC 0264-7750
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 4 recorded enforcement report(s) associated with Lactated Ringers (NDC 0264-7750). A significant event, classified as Class I, was initiated on Apr 28, 2026 by B. Braun Medical Inc.. The reported reason for this action was: "Presence of Particulate Matter."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class I Ongoing
Presence of Particulate Matter.
Apr 28, 2026
May 13, 2026
95,412 containers
Recall Profile & Regulatory Data
Event ID
98795
Classification
Class I
Enforcement Status
Ongoing
Recalling Firm
B BRAUN MEDICAL INC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S.A. Nationwide
Product Description
Lactated Ringer's Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-7750-07.
Batch or Lot Expiration Information
Lot# :J4P756, J4S843, Exp 5/31/2027
Affected Packages Involved in this Recall
0264-7750-07Product
Class I Ongoing
Presence of Particulate Matter
Aug 18, 2025
Sep 10, 2025
46,032 containers
Recall Profile & Regulatory Data
Event ID
97433
Classification
Class I
Enforcement Status
Ongoing
Recalling Firm
B BRAUN MEDICAL INC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S.A. Nationwide
Product Description
Lactated Ringers's Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-7750-07
Batch or Lot Expiration Information
Lot# : J4S807, Exp 5/31/2027
Affected Packages Involved in this Recall
0264-7750-07Product
August 2025 Class II Recall: Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites.
Recall Number
Class II Ongoing
Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites.
Aug 04, 2025
Aug 20, 2025
74,088 containers
Recall Profile & Regulatory Data
Event ID
97368
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
B BRAUN MEDICAL INC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the US
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.
Batch or Lot Expiration Information
Lot# : J5C802, J5C917, J5C918, Exp. 08/31/2027
Affected Packages Involved in this Recall
0264-7750-00Product
0264-7750-10Product
0264-7750-20Product
Class II Terminated
Lack of assurance of sterility: bags have the potential to leak..
Mar 22, 2024
Apr 10, 2024
7,800 bags
Recall Profile & Regulatory Data
Event ID
94272
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
B. Braun Medical Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
Jul 01, 2025
Product Description
Lactated Ringer's Injection USP, 1000mL, EXCEL CONTAINER, Rx only, B.Braun Medical Inc., Bethlehem, PA 18018, NDC 0264-7750-00
Batch or Lot Expiration Information
Lot# : J3N023, Exp: 31 March 2026
Affected Packages Involved in this Recall
0264-7750-00Product
0264-7750-10Product
0264-7750-20Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
