FDA Drug Recalls

Recalls / Active ingredient / Sodium Chloride

Sodium Chloride

94 FDA drug recalls involving the active ingredient “Sodium Chloride21 Class I.

DateClassProductFirm
2025-10-27Class II0.9% SODIUM CHLORIDE Injection, USP, 100 mL, Rx only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDOtsuka ICU Medical LLC
2025-08-26Class II0.9% SODIUM CHLORIDE IRRIGATION USP. ISOTONIC SOLUTION FOR IRRIGATION, 3000mL, Rx only, B. Braun Medical Inc.,B BRAUN MEDICAL INC
2025-08-18Class ILactated Ringers's Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-3524B BRAUN MEDICAL INC
2025-08-18Class I0.9% Sodium Chloride Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-35B 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
2025-08-04Class II0.9% Sodium Chloride Injection USP, L 8000, 1000mL Excel Container, Rx Only, Sterile, nonpyrogenic, single dosB BRAUN MEDICAL INC
2025-06-16Class II0.9% Sodium Chloride Injection USP, 500 mL, packaged in 500 mL excel containers and further packaged 24 per caB BRAUN MEDICAL INC
2025-05-27Class II0.9% Sodium Chloride Injection, USP, Flexible Plastic Container, Rx Only Fresenius Medical Care North America,Fresenius Medical Care Holdings, Inc.
2025-03-31Class II0.9% Sodium chloride Irrigation USP, Isotonic Solution for Irrigation, 500 mL Plastic Irrigation Container (PIB. Braun Medical Inc
2024-07-24Class I0.9% Sodium Chloride Injection USP, E8000, 1000mL container, Rx only, B. Braun Medical Inc., Irvine, CA, NDC 0B. 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 PD-2 Peritonial Dialysis Solution with 1.5% Dextrose, 5000 mL AMBU-FLEX ll Container with yellow pull Baxter Healthcare Corporation
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
2023-08-02Class III0.9% Sodium Chloride Injection USP, 1000 mL Excel Plus Container, Rx only, B. Braun Medical Inc. Bethlehem, PAB. Braun Medical Inc.
2023-07-05Class II0.9% Sodium Chloride Injection USP, 1000 mL Excel Plus Container, Rx only, B. Braun Medical Inc. Bethlehem, PAB. Braun Medical Inc.
2023-05-23Class IISodium Chloride 0.9% Injection, USP, 1000 mL bags, 12 bags per carton, Rx only, Fresenius Medical Care North AFresenius Medical Care Holdings, Inc.
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
2023-02-10Class II0.9% Sodium Chloride Injection, USP, 1000 mL Excel Plus Container, Rx Only, B. Braun Medical Inc. Bethlehem, PB. Braun Medical Inc.
2023-02-10Class II0.9% Sodium Chloride Injection, USP, 500 mL Excel Plus Container, Rx Only, B. Braun Medical Inc. Bethlehem, PAB. Braun Medical Inc.
2023-01-12Class II0.9% Sodium Chloride Injection, USP, 100 mL Single-Dose Container bag, Rx Only, Nephron Pharmaceuticals CorporNephron Sc Inc
2022-11-25Class II0.9% Sodium Chloride Injection USP 1000 mL Single-dose container Rx only NDC 0264-5802-00 B. Braun Medical IncB. Braun Medical, Inc.
2022-11-22Class II0.9% Sodium Chloride Injection, USP, Each 100 mL contains: SODIUM CHLORIDE, USP - 900 mg, WATER FOR INJECTION,Fresenius Medical Care Holdings, Inc.
2022-11-09Class II0.9% Sodium Chloride Injection, USP, 100 mL flexible container bag, Rx Only, ICU Medical, Inc., Lake Forest, IICU Medical Inc
2022-10-11Class II0.9% Sodium Chloride Injection, USP, Each 100 mL contains: SODIUM CHLORIDE, USP - 900 mg, WATER FOR INJECTION,Fresenius Medical Care Holdings, Inc.
2022-04-27Class IIGaviLyte -C (Polyethylene Glycol 3350, 240 g) and electrolytes for Oral Solution, USP with flavor pack NDC# 4Lupin Pharmaceuticals Inc.
2022-04-13Class IIBSS Sterile Irrigating Solution (balanced salt solution), 500 mL bottle, Rx only, MFG: Alcon Surgical Inc, NDCMckesson Medical-Surgical Inc. Corporate Office
2022-04-13Class IIBSS Sterile Irrigating Solution (balanced salt solution), 15 mL bottle, Rx only, MFG: Alcon Surgical Inc, NDC Mckesson Medical-Surgical Inc. Corporate Office
2022-02-25Class II0.9% Sodium Chloride Injection USP, 250 mL Excel Container, Rx only, B. Braun Medical Inc., Bethlehem, PA, NDCB. Braun Medical, Inc.
2021-07-29Class IIGaviLyteTM - C PEG-3350 (240g) and Electrolytes for Oral Solution, USP with Flavor Pack Manufactured by Novel Novel Laboratories, Inc. d.b.a LUPIN
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 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 2.5% Dextrose, Low magnesium, Low Calcium and attached stay safe ExcFresenius 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.
2021-04-14Class IIDelflex Peritoneal Dialysis Solution with 1.5% Dextrose, LM/LC, packaged in a case containing 2 x 6 Liter bagsFresenius Medical Care, North America
2021-03-09Class II0.9% SODIUM CHLORIDE Irrigation, USP 1000 mL Semi-Rigid Bottle, Rx only, Manufactured for ICU Medical, Inc., LICU Medical Inc
2020-12-07Class IISodium Chloride Injection, USP, 0.9%, 0.308 mOsmol/ml, 2mL Single Dose Vial, Rx Only, Mfd. by. West-ward EatonHikma Pharmaceuticals USA Inc.
2020-11-03Class IISodium Chloride Injection, USP, 0.9%, 0.308 mOsmol/mL, 2mL Single Dose Vial, Preservative Free, For use as a sHikma Pharmaceuticals USA Inc.
2019-11-19Class II0.9% Sodium Chloride Irrigation USP 5000 mL bags, Rx Only, Baxter Healthcare Corporation Deerfield, IL 60015,Baxter Healthcare Corporation
2019-09-13Class IIISodium Chloride Injection USP 0.9%, packaged in 1 - 125 mL Ultraject Prefilled Syringe For Power Injection perGUERBET LLC
2019-07-18Class II0.9% Sodium Chloride Injection USP, 100 mL Viaflex Container, Rx Only, Baxter Healthcare Corporation, DeerfielBaxter Healthcare Corporation
2019-07-02Class IIActivEyes Altachlore Solution, 15 mL (1/2 FL OZ), Manufactured by Altaire Pharmaceuticals Inc., Aquebogue, NY Altaire Pharmaceuticals, Inc.
2019-07-02Class IIWalgreens Sodium Chloride Ophthalmic Solution, 5% Hypertonicity Eye Drops, 0.5 oz (15 mL), Distributed by : WaAltaire Pharmaceuticals, Inc.
2019-07-02Class IIActivEyes Altachlore Sodium Chloride Hypertonicity Opthalmic Ointment, 5%, Manufactured by: Altaire PharmaceutAltaire Pharmaceuticals, Inc.
2019-07-02Class IIWalgreens Sodium Chloride Ophthalmic Ointment, 5% Hypertonicity Eye Ointment Sterile, Net Wt. 0.125 oz (3.5 g)Altaire Pharmaceuticals, Inc.
2019-03-19Class IIGavilyte-N, PEG-3350, Sodium chloride, Sodium Bicarbonate and Potassium Chloride for Oral Solution, Rx only, MLUPIN SOMERSET
2019-01-02Class IIDianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextrose, 2000 mL UltraBag container baBaxter Healthcare Corporation
2018-11-15Class ISODIUM CHLORIDE INJECTION, USP, 0.9%, 20 mL Single Dose Vial, packaged in a 25-unit tray, Rx Only, APP PharmacFresenius Kabi USA, LLC
2018-11-15Class ISODIUM CHLORIDE INJECTION, USP, 0.9%, 10 mL Single Dose Vial, packaged in a 25-unit tray, Rx Only, APP PharmacFresenius Kabi USA, LLC
2018-09-06Class II0.9% Sodium Chloride Injection USP 50 mL Viaflex container Baxter Healthcare Corporation Deerfield, IL 60015 -Baxter Healthcare Corporation
2018-08-21Class II0.9% Sodium Chloride Injection USP 100 mL bags, Rx only, Baxter Healthcare Corporation Deerfield, IL 60015 USABaxter Healthcare Corporation
2018-02-16Class II0.9% Sodium Chloride Irrigation USP, 1000 mL Plastic Irrigation Container (PIC), Rx only, B. Braun Medical IncB. Braun Medical Inc
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
2017-07-06Class II0.9% Sodium Chloride Injection USP, 250 mL VIAFLEX Container bag, Rx only, Baxter Healthcare Corporation, DeerBaxter Healthcare Corporation
2017-07-06Class II0.9% Sodium Chloride Injection, USP, 100 mL VIAFLEX Container, Rx Only, Baxter Healthcare Corporation, DeerfiBaxter Healthcare Corporation
2016-02-05Class II0.9% Sodium Chloride Irrigation, USP, 500 mL bottle, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 600Baxter Healthcare Corp.
2016-01-21Class II0.9% Sodium Chloride Injection USP, MINI-BAG Plus Container, 100 mL VIAFLEX Single Dose Container bags, Rx onlBaxter Healthcare Corp.
2016-01-21Class I0.9% Sodium Chloride Injection USP, MINI-BAG Plus Container, 100 mL VIAFLEX Single Dose Container bags, Rx onlBaxter Healthcare Corp.
2016-01-21Class ICLINIMIX E 5/15 sulfite-free (5% Amino Acid with Electrolytes in 15% Dextrose with Calcium) Injection, 1000 mLBaxter Healthcare Corp.
2015-12-15Class I0.9% Sodium Chloride Injection, USP, 250 mL VIAFLEX Plastic Container Bag, Rx Only, Manufactured by Baxter HeaBaxter Healthcare Corp.
2015-09-02Class II0.9% Sodium Chloride Injection, USP, 100 mL MINI-BAG VIAFLEX Container, Single Dose Container, Rx Only, BaxterBaxter Healthcare Corporation
2015-07-17Class I0.9% Sodium Chloride Injection USP MINI-BAG Plus Container, 100 mL VIAFLEX Single Dose Container bags, Rx onlyBaxter Healthcare Corp.
2015-07-17Class I0.9% Sodium Chloride Injection USP, 50 mL Single Dose VIAFLEX Container bags, Rx only, Baxter Healthcare CorpoBaxter Healthcare Corp.
2015-07-02Class II0.9% Sodium Chloride Injection USP, 500 mL in VIAFLEX Plastic Container, Baxter Healthcare Corporation DeerfieBaxter Healthcare Corp.
2015-04-07Class II0.9% Sodium Chloride Injection, USP, 100 mL ADD-Vantage Unit, Rx only, Manufactured by Hospira Inc., Lake ForeHospira Inc.
2015-03-24Class ILactated Ringers Injection, USP, 250mL VIAFELX Plastic bags, Manufactured by Baxter Healthcare Corporation 65 Baxter Healthcare Corp.
2015-03-24Class I0.9% Sodium Chloride Injection, USP, in 250mL VIAFLEX Plastic bags, Manufactured by Baxter Healthcare CorporatBaxter Healthcare Corp.
2015-03-23Class IIClinimix E 5/20 sulfite-free (5% amino-acid with electrolytes in 20% dextrose with calcium) Injection, 2000 mLBaxter Healthcare Corp
2015-03-23Class II0.9% Sodium Chloride Injection, USP, 50 mL, VIAFLEX Plastic Container Multi Pack, Rx Only, Baxter Healthcare CBaxter Healthcare Corp
2015-03-18Class II0.9% Sodium Chloride Injection, USP, 500 mL in VIAFLEX Plastic Container, Rx only, Manufactured by Baxter HealBaxter Healthcare Corp.
2014-12-04Class I0.9% Sodium Chloride Injection USP, 100 mL MINI-BAG Plus Container, Rx only, Baxter Healthcare Corporation, DeBaxter Healthcare Corp
2014-11-25Class IIClinimix E 4.25/10 sulfite-free (4.25% Amino Acid with Electrolytes in 10% Dextrose with Calcium) Injections, 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.
2014-07-30Class II0.9% Sodium Chloride Injection, USP, 500 mL, VIAFLEX Plastic Container, Baxter Healthcare Corporation, DeerfieBaxter Healthcare Corp.
2014-07-11Class I0.9% Sodium Chloride Injection USP, packaged in a) 50 mL VIAFLEX Container bags, NDC 0338-0049-41, Product CodBaxter Healthcare Corp.
2014-07-11Class I0.9% Sodium Chloride Injection USP MINI-BAG Plus Container, 100 mL VIAFLEX Single Dose Container bags, Rx onlyBaxter Healthcare Corp.
2014-04-21Class II0.9% Sodium Chloride Irrigation, USP, 1000 mL,Not for Injection, Manufactured by Baxter Healthcare CorporatioBaxter Healthcare Corp.
2014-04-10Class IIMuro 128 (sodium chloride) hypertonicity ophthalmic ointment, 5%, packaged in a) 1 g tube per carton, professiBausch & Lomb, Inc.
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.
2013-11-27Class II0.45% Sodium Chloride Injection USP, 1000 mL. Rx only, Manufactured by B. Braun Medical Inc, 2525 McGaw Ave, B. Braun Medical Inc
2013-11-21Class I0.9% Sodium Chloride Injection, USP, packaged in a) 50 mL Single dose VIAFLEX plastic containers (Product codeBaxter Healthcare Corp.
2013-11-21Class I0.9 % Sodium Chloride Injection USP in PAB 50 mL partial fill in 100 mL PAB Container, Catalog No. S8004-5384,B. Braun Medical Inc
2013-11-18Class IClinimix E 4.25/10 sulfite-free (4.25% Amino Acid with Electrolytes in 10% Dextrose with Calcium) Injection, 2Baxter Healthcare Corp.
2013-11-18Class IClinimix 4.25/25 sulfite-free (4.25% Amino Acid in 25% Dextrose) Injection, 1000 mLCLARITY Dual Chamber ContaiBaxter 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.
2013-06-27Class IISodium Chloride Injection, USP, 0.9%, 20 mL Single-dose Fliptop Plastic Vial, packaged in 25 vial Units per caHospira Inc.
2013-05-21Class IISodium Chloride Injection, USP, a) Product code 2B1301- 50 mL in Viaflex Container Quad Pack (NDC 0338-0049-11Baxter Healthcare Corp.
2013-05-21Class II0.9% Sodium Chloride Injection, USP, in MINI-BAG Plus Container, a) 50 mL (NDC 0338-0553-11), b) 100 mL (NDC 0Baxter Healthcare Corp.
2013-02-27Class II0.9% Sodium Chloride Injection, USP, 50 mL Mini-Bag Plus Container, Rx only, distributed by Baxter Healthcare Baxter Healthcare Corp.
2012-05-04Class II0.45% Sodium Chloride Injection, USP, Rx Only, 250 mL, by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7132-Hospira Inc.