Sodium Bicarbonate recalls

The FDA has published 34 recalls involving Sodium Bicarbonate since 2012. The latest was reported on 17 Sep 2025. Most were for sterility. Exela Pharma Sciences has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls34since 2012

Last 12 months0reported

Class I1132% of total

Ongoing7latest 17 Sep 2025

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 0 1 0May 0 0 1Aug 1 0 0Nov 0 0 0Feb 0 0 0May 0 0 0Aug 0 0

Severity split

Class I 11 32%Class II 23 68%Class III 0 0%

Why sodium bicarbonate is recalled

Companies

By year

202539%
202426%
202339%
20221029%
202126%
201926%
201726%
201613%
201413%
2013721%

Ongoing sodium bicarbonate recalls

7 active

Reported	Class	Recall	Company	Reason	Where
17 Sep 2025Drug	CLASS II	4.2% Sodium Bicarbonate Injection, USP, 5 mEq/ (0.5 mEq/mL) recalledSodium Bicarbonate	Exela Pharma Sciences	Lead & Heavy Metals	Nationwide
27 Aug 2025Drug	CLASS II	Vial Label: 8.4% Sodium Bicarbonate Injection, USP, 50mEq recalledSodium Bicarbonate	Pfizer	Sterility	Nationwide
2 Apr 2025Drug	CLASS II	8.4% Sodium Bicarbonate Injection, USP, 50 mEq/ (1 mEq/mL) recalledSodium Bicarbonate	Exela Pharma Sciences	Sterility	Nationwide
24 Jan 2024Drug	CLASS I	8.4 % Sodium Bicarbonate Injection, USP 50 mEq/ (1 mEq/mL) recalledSodium Bicarbonate	Pfizer	Particulate Matter	Nationwide
24 Jan 2024Drug	CLASS I	4.2% Sodium Bicarbonate Injection, USP 5 mEq/ (0.5 mEq/mL) recalled	Pfizer	Particulate Matter	Nationwide
29 Nov 2023Drug	CLASS I	8.4% Sodium Bicarbonate Injection, USP, 50 mEq/ (1mEq/mL) recalledSodium Bicarbonate	Exela Pharma Sciences	Particulate Matter	Nationwide

All sodium bicarbonate recalls, newest first

34 total

Reported	Class	Recall	Company	Reason	Where
17 Sep 2025Drug	CLASS II	4.2% Sodium Bicarbonate Injection, USP, 5 mEq/ (0.5 mEq/mL) recalledSodium Bicarbonate	Exela Pharma Sciences	Lead & Heavy Metals	Nationwide
27 Aug 2025Drug	CLASS II	Vial Label: 8.4% Sodium Bicarbonate Injection, USP, 50mEq recalledSodium Bicarbonate	Pfizer	Sterility	Nationwide
2 Apr 2025Drug	CLASS II	8.4% Sodium Bicarbonate Injection, USP, 50 mEq/ (1 mEq/mL) recalledSodium Bicarbonate	Exela Pharma Sciences	Sterility	Nationwide
24 Jan 2024Drug	CLASS I	8.4 % Sodium Bicarbonate Injection, USP 50 mEq/ (1 mEq/mL) recalledSodium Bicarbonate	Pfizer	Particulate Matter	Nationwide
24 Jan 2024Drug	CLASS I	4.2% Sodium Bicarbonate Injection, USP 5 mEq/ (0.5 mEq/mL) recalled	Pfizer	Particulate Matter	Nationwide
29 Nov 2023Drug	CLASS I	8.4% Sodium Bicarbonate Injection, USP, 50 mEq/ (1mEq/mL) recalledSodium Bicarbonate	Exela Pharma Sciences	Particulate Matter	Nationwide
15 Nov 2023Drug	CLASS I	4.2% Sodium Bicarbonate Injection, USP 5 mEq/ (0.5mEq/mL) recalled	Pfizer	Particulate Matter	Nationwide
26 Jul 2023Drug	CLASS II	Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq recalled by SterRx	SterRx	Sterility	Nationwide
21 Dec 2022Drug	CLASS I	8.4% Sodium Bicarbonate Injection, USP 50 mEq recalledSodium Bicarbonate	Exela Pharma Sciences	Foreign Material	Nationwide
21 Dec 2022Drug	CLASS I	8.4% Sodium Bicarbonate Injection, USP 50 mEq recalled	Exela Pharma Sciences	Foreign Material	Nationwide
2 Nov 2022Drug	CLASS I	8.4% Sodium Bicarbonate Injection, USP 50 mEq recalled	Exela Pharma Sciences	Foreign Material	Nationwide
2 Nov 2022Drug	CLASS I	8.4% Sodium Bicarbonate Injection, USP 50 mEq recalledSodium Bicarbonate	Exela Pharma Sciences	Foreign Material	Nationwide
27 Jul 2022Drug	CLASS II	8.4% Sodium Bicarbonate Injection, USP (84 mg/mL) 1 mEq/mL syringe recalled	Nephron Sterile Compounding Center	Sterility	Nationwide
15 Jun 2022Drug	CLASS II	Sodium Bicarbonate Tablets, 600 mg, MFG: Major Pharma recalled	Mckesson Medical-Surgical Inc. Corporate Office	Manufacturing (CGMP) Deviations	Nationwide
8 Jun 2022Drug	CLASS II	8.4% Sodium Bicarbonate Injection, USP, 1 mEq/mL (84 mg/mL) recalled	Nephron Sterile Compounding Center	Sterility	Nationwide
19 Jan 2022Drug	CLASS II	8.4% Sodium Bicarbonate Injection, USP 50 mEq/ (1 mEq/mL) vials recalled	Exela Pharma Sciences	Sterility	Nationwide
5 Jan 2022Drug	CLASS II	Sodium Bicarbonate in 5% Dextrose Injection recalled by SterRx	SterRx	Sterility	Nationwide
5 Jan 2022Drug	CLASS II	Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq recalled by SterRx	SterRx	Sterility	Nationwide
1 Sep 2021Drug	CLASS II	Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq recalled by SterRx	SterRx	Sterility	Nationwide
1 Sep 2021Drug	CLASS I	Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq recalled by SterRx	SterRx	Sterility	Nationwide
9 Oct 2019Drug	CLASS II	Sodium Bicarbonate 8.4%, 4,200 mg / 50 mEq / (84 mg/mL) recalled	KRS Global Biotechnology	Sterility	Nationwide
10 Apr 2019Drug	CLASS I	8.4% Sodium Bicarbonate Injection, USP 50 mEq (1 mEq/mL) recalled	Pfizer	Particulate Matter	PR
16 Aug 2017Drug	CLASS II	Sodium Bicarbonate 8.4% Injection Solution, 50 mEq recalled	Cantrell Drug	Sterility	Nationwide
11 Jan 2017Drug	CLASS II	Sodium Bicarbonate, 8.4% Injectable MultiDose vial recalled	Wells Pharmacy Network	Sterility	Nationwide
1 Jun 2016Drug	CLASS I	8.4% Sodium Bicarbonate Injection, USP 50mEq (1mEq/mL) (84 mg/mL) recalled	Hospira	Particulate Matter	Nationwide
22 Jan 2014Drug	CLASS II	Sodium Bicarbonate Tablet, 650 mg, Over The Counter recalled	Aidapak Services	Labeling Errors	4 states
24 Jul 2013Drug	CLASS II	Sodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer recalled	Church & Dwight	Foreign Material	Nationwide
24 Jul 2013Drug	CLASS II	Sodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer recalled	Church & Dwight	Foreign Material	Nationwide
24 Jul 2013Drug	CLASS II	Sodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer recalled	Church & Dwight	Foreign Material	Nationwide
24 Jul 2013Drug	CLASS II	Sodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer recalled	Church & Dwight	Foreign Material	Nationwide

Should you stop taking Sodium Bicarbonate?

Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.