FDA Drug Recalls

Recalls / Active ingredient / Potassium Chloride

Potassium Chloride

27 FDA drug recalls involving the active ingredient “Potassium Chloride10 Class I.

DateClassProductFirm
2025-10-29Class IPOTASSIUM CHLORIDE Inj., 10 mEq total in 100 mL Flexible Container, Highly concentrated 100 mEq/L, Rx Only, ICOtsuka ICU Medical LLC
2025-10-29Class IPOTASSIUM CHLORIDE Inj., 20 mEq total in 50 mL Flexible Container, Highly concentrated 400 mEq/L, Rx Only, ICUOtsuka ICU Medical LLC
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
2025-02-13Class IPOTASSIUM CHLORIDE Inj., 20 mEq total in 100 mL flexible container 24 x case, 200 mEq/L, Rx Only, ICU Medical,ICU Medical, Inc.
2025-02-13Class IPOTASSIUM CHLORIDE Inj., 10 mEq total in 100 mL, 100 mEq/L flexible container, Rx Only, ICU Medical, Inc., LakICU Medical, Inc.
2025-01-30Class IIPotassium Chloride Extended-Release Tablets, USP, 10 mEq (750 mg), 100 Tablets per carton (10 x 10 unit dose bThe Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
2024-06-25Class IPotassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, a).100-count bottle ( NDC 68001-396-00),Amerisource Health Services LLC
2024-05-30Class IIPotassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 500-count bottle, Rx Only, Manufactured Glenmark Pharmaceuticals Inc., USA
2024-05-30Class IPotassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 100-count bottle, Rx Only, Manufactured Glenmark Pharmaceuticals Inc., USA
2024-05-30Class IIPotassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 100-count bottle, Rx Only, Manufactured Glenmark Pharmaceuticals Inc., USA
2024-05-30Class IPotassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 500-count bottle, Rx Only, Manufactured Glenmark Pharmaceuticals Inc., USA
2024-03-22Class IILactated Ringer's Injection USP, 1000mL, EXCEL CONTAINER, Rx only, B.Braun Medical Inc., Bethlehem, PA 18018, B. Braun Medical Inc
2024-03-06Class IIPotassium Chloride for Injection Concentrate USP, 500 mEq/250 mL (2 mEq/mL), 250 mL Bag, Rx only, B. Braun MedB. Braun Medical 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
2021-09-27Class IIPotassium Chloride Extended-Release Tablets, USP 10 mEq (750 mg), 500 Tablets, Rx Only, Manufactured by: StridStrides Pharma 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
2020-08-24Class IIStrides Pharma Inc.Potassium Chloride Extended-Release Tablets, USP 8mEq (600 mg) 100 Tablets Rx Only ManufaStrides Inc.
2020-02-17Class IIIPotassium Chloride Extended-Release Tablets USP, 10mEq (750mg), 1000-count bottle, Rx only, Manufactured by: Strides Pharma Science Limited
2019-03-19Class IIGavilyte-N, PEG-3350, Sodium chloride, Sodium Bicarbonate and Potassium Chloride for Oral Solution, Rx only, MLUPIN SOMERSET
2015-04-28Class IIKABIVEN [(3.9%) Lipid Injectable Emulsion with (3.1%) Amino Acids and Electrolytes and (9.8%) Dextrose; SulfitFresenius Kabi USA, LLC
2015-03-24Class ILactated Ringers Injection, USP, 250mL VIAFELX Plastic bags, Manufactured by Baxter Healthcare Corporation 65 Baxter Healthcare Corp.
2014-11-10Class IIPotassium Chloride Injection, 10mEq per 100mL, 100 mL Sterile single dose container bags, Rx only, Baxter USA,Baxter Healthcare Corp.
2014-09-08Class IIPotassium Chloride Injection, 10 mEq per 100 mL, Highly Concentrated (100 mEq/L), 100 mL Sterile single dose cBaxter Healthcare Corp
2014-07-11Class IPotassium Chloride Injection, 20 mEq per 50 mL, 50 mL Sterile Single Dose Container bag, Rx only, Baxter HealtBaxter Healthcare Corp.