FDA Drug Recalls

Recalls / Generics / Sodium Bicarbonate

Sodium Bicarbonate

8 FDA drug recalls involving generic “Sodium Bicarbonate” — 4 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
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
2022-04-13Class IISodium Bicarbonate Tablets, 600 mg, 1000-count bottle, MFG: Major Pharma, NDC 0536-1047-10Mckesson Medical-Surgical Inc. Corporate Office