FDA Drug Recalls

Recalls / Active ingredient / Sodium Bicarbonate

Sodium Bicarbonate

14 FDA drug recalls involving the active ingredient “Sodium Bicarbonate4 Class I.

DateClassProductFirm
2025-08-04Class IIVial Label: 8.4% Sodium Bicarbonate Injection, USP, 50mEq/50 mL (1 mEq/mL), Rx only, Hospira, Inc., Lake ForesPFIZER INC
2025-07-30Class II4.2% Sodium Bicarbonate Injection, USP, 5 mEq/10 mL (0.5 mEq/mL), For Intravenous Use Only, 10 mL Single Dose Exela Pharma Sciences LLC
2025-03-07Class II8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1 mEq/mL), 25 x 50 mL Single Dose Vials per carton, For Exela Pharma Sciences LLC
2024-02-02Class IIOmeprazole and Sodium Bicarbonate For Oral Suspension 40mg/1,680mg, This packet contains 40mg of omeprazole aBausch Health Companies, Inc.
2023-12-21Class I8.4 % Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL), Lifeshield, Glass ABBOJECT Unit of Use SyringPfizer Inc.
2023-10-18Class I8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1mEq/mL), a) 20x50 mL Single Dose Vials (Vial NDC 51754-Exela Pharma Sciences LLC
2022-11-28Class I8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials, packaged in cartons ofExela Pharma Sciences LLC
2022-10-04Class I8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials, packaged in cartons ofExela Pharma Sciences LLC
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 IISodium Bicarbonate Tablets, 600 mg, 1000-count bottle, MFG: Major Pharma, NDC 0536-1047-10Mckesson Medical-Surgical Inc. Corporate Office
2022-04-13Class IIE-Z-Gas II, Effervescent Granules, Net Weight: 4 g, 50 packets per box, MFG: Bracco Diagnostics Inc., NDC 0270Mckesson Medical-Surgical Inc. Corporate Office
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
2019-03-19Class IIGavilyte-N, PEG-3350, Sodium chloride, Sodium Bicarbonate and Potassium Chloride for Oral Solution, Rx only, MLUPIN SOMERSET
2014-09-18Class IIIE-Z- GAS II EFFERVESCENT GRANULES Antacid/Antiflatulent ,4 g (0.14 oz), 50 -count box, Rx Only, Manufactured Bracco Diagnostic Inc