FDA Drug Recalls

Recalls / Active ingredient / Sodium Lactate

Sodium Lactate

22 FDA drug recalls involving the active ingredient “Sodium Lactate4 Class I.

DateClassProductFirm
2025-08-18Class ILactated Ringers's Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-3524B BRAUN MEDICAL INC
2025-08-04Class IILactated Ringer's Injection USP, L 7500, 1000mL Excel Container, Rx Only, Sterile, nonpyrogenic, single dose cB BRAUN MEDICAL INC
2024-06-18Class IIDELFLEX PERITONEAL DIALYSIS SOLUTION With LOW MAGNESIUM / LOW CALCIUM 4.25% DEXTROSE and attached stay "safe EFresenius Medical Care Holdings, Inc.
2024-06-17Class IIDianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose, For Intraperitoneal AdministrBaxter Healthcare Corporation
2024-03-22Class IILactated Ringer's Injection USP, 1000mL, EXCEL CONTAINER, Rx only, B.Braun Medical Inc., Bethlehem, PA 18018, B. Braun Medical Inc
2023-12-28Class IIDELFLEX Peritoneal Dialysis Solution in Biofine container 1.5% Dextrose, packaged in 6000mL bags, Rx only, FreFresenius Medical Care Holdings, Inc.
2023-08-11Class IIDIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution 1.5% Dextrose, packaged in a) 2000 mL AMBU-FLEX IBaxter Healthcare Corporation
2023-08-11Class IIDianeal PD-2 Peritonial Dialysis Solution with 1.5% Dextrose, 5000 mL AMBU-FLEX ll Container with yellow pull Baxter Healthcare Corporation
2023-03-15Class IIDianeal PD-2 Peritonial Dialysis Solution with 1.5% Dextrose, 3000 mL per Ambu-Flex II Container bag, Rx Only,Baxter Healthcare Corporation
2023-03-15Class IIDianeal Low Calcium (2.5 mEq/L) Peritonial Dialysis Solution with 1.5% Dextrose, packaged in a) 5000 mL per AmBaxter Healthcare Corporation
2021-04-28Class IIIDELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, Low magnesium, Low Calcium and attached stay safe ExcFresenius Medical Care Holdings, Inc.
2021-04-28Class IIIDELFLEX Peritoneal Dialysis Solution with 2.5 % Dextrose, Low Magnesium, Low Calcium, packaged in a) 3000 mL 2Fresenius Medical Care Holdings, Inc.
2021-04-28Class IIIDELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, Low magnesium, Low Calcium, packaged in a) 3000 mL baFresenius Medical Care Holdings, Inc.
2021-04-28Class IIIDELFLEX Peritoneal Dialysis Solution with 4.25% Dextrose, Low magnesium, Low Calcium and attached stay safe ExFresenius Medical Care Holdings, Inc.
2021-04-28Class IIIDELFLEX Peritoneal Dialysis Solution with 2.5% Dextrose, Low magnesium, Low Calcium and attached stay safe ExcFresenius Medical Care Holdings, Inc.
2021-04-14Class IIDelflex Peritoneal Dialysis Solution with 1.5% Dextrose, LM/LC, packaged in a case containing 2 x 6 Liter bagsFresenius Medical Care, North America
2019-01-02Class IIDianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextrose, 2000 mL UltraBag container baBaxter Healthcare Corporation
2017-12-20Class IIDELFLEX Peritoneal Dialysis Solution, 2.5% Low Mg/Low Ca Single Bag, packaged in a) 3L (4 pack, NDC 49230-209-Fresenius Medical Care Renal Therapies Group, LLC
2015-03-24Class ILactated Ringers Injection, USP, 250mL VIAFELX Plastic bags, Manufactured by Baxter Healthcare Corporation 65 Baxter Healthcare Corp.
2014-08-07Class IDianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose, 5000 mL Ambu-Flex II containeBaxter Healthcare Corp.
2014-02-11Class IDianeal PD-2 Peritoneal Dialysis Solution with 1.5% Dextrose, 6000 mL Ambu-Flex II container, Rx only, Baxter Baxter Healthcare Corp.
2013-07-24Class IIDIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextrose, 5000 mL container, Rx only, BBaxter Healthcare Corp.