thejoe Sodium Bicarbonate

Sodium Bicarbonate recalls: 8 FDA reports

Recalls involving Sodium Bicarbonate. What was wrong with each batch, and how the FDA graded the risk.

8Reports

4Class I

5Ongoing

2025-09-17Most recent

4 Class I on this page

Class I means the FDA judged there was a reasonable probability of serious harm or death. Check the lot numbers against anything you hold.

What the classes mean

The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.

Class	What the FDA is saying
Class I	There is a reasonable probability that using this will cause serious harm or death.
Class II	It may cause temporary or reversible harm. Serious harm is unlikely.
Class III	It breaks a rule but is unlikely to hurt anyone. Often a labelling fault.

Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.

By class

Class	Reports
Class I	4
Class II	4

By year reported

Year	Reports
2022	3
2023	1
2024	1
2025	3

Checking whether it affects you

The lot or code number is what matters. Not the product name. A recall covers specific lots. Yours may not be one of them.

Check the code on your package against the report. The FDA keeps the current list at fda.gov/safety/recalls.

The reports

The text below is quoted from the FDA record word for word.

4.2% Sodium Bicarbonate Injection, USP, 5 mEq/10 mL (0.5 mEq/mL), For Intravenous Use Only, 10 mL Single Dose

D-0620-2025 · Class II · reported 2025-09-17 · Ongoing

Why it was recalled: Failed Impurities/Degradation Specifications: out of specification results for arsenic in the impurities tested.
Product: 4.2% Sodium Bicarbonate Injection, USP, 5 mEq/10 mL (0.5 mEq/mL), For Intravenous Use Only, 10 mL Single Dose Vial, Rx Only, Manufactured and Distributed by: Exela Pharma Sciences, LLC, Lenoir, NC 28645 USA, NDC 51754-5012-1 (vial); 51754-5012-4 (carton)
Where it went: Nationwide in the USA
How much: N/A

Vial Label: 8.4% Sodium Bicarbonate Injection, USP, 50mEq/50 mL (1 mEq/mL), Rx only, Hospira, Inc., Lake Fores

D-0591-2025 · Class II · reported 2025-08-27 · Ongoing

Why it was recalled: Lack of Assurance of Sterility.
Product: Vial Label: 8.4% Sodium Bicarbonate Injection, USP, 50mEq/50 mL (1 mEq/mL), Rx only, Hospira, Inc., Lake Forest, IL 60045, USA, NDC 0409-6637-24. Case NDC: 00409-6637-14.
Where it went: U.S. Nationwide
How much: 15,750 vials

8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1 mEq/mL), 25 x 50 mL Single Dose Vials per carton, For

D-0303-2025 · Class II · reported 2025-04-02 · Ongoing

Why it was recalled: Lack of Assurance of Sterility
Product: 8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1 mEq/mL), 25 x 50 mL Single Dose Vials per carton, For Intravenous Use Only, Rx Only, Manufactured by: Exela Pharma Sciences, LLC, Lenoir, NC 28645. NDC Inner Vial: 51754-5001-1; NDC Carton: 51754-5001-4
Where it went: Nationwide
How much: 103,950 vials

Class I

8.4 % Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL), Lifeshield, Glass ABBOJECT Unit of Use Syring

D-0234-2024 · Class I · reported 2024-01-24 · Ongoing

Why it was recalled: Presence of Particulate Matter; identified as glass
Product: 8.4 % Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL), Lifeshield, Glass ABBOJECT Unit of Use Syringe, Rx Only, 50 mL Syringe per Carton, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-6637-24 (carton), 0409-6637-14 (case).
Where it went: Nationwide in the USA and Puerto Rico.
How much: 21200 Cartons

Class I

8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1mEq/mL), a) 20x50 mL Single Dose Vials (Vial NDC 51754-

D-0116-2024 · Class I · reported 2023-11-29 · Ongoing

Why it was recalled: Presence of Particulate Matter: Silicone
Product: 8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1mEq/mL), a) 20x50 mL Single Dose Vials (Vial NDC 51754-5001-1; Carton NDC 51754-5001-5) and b) 25x50 mL Single Dose Vials (Vial NDC 51754-5001-1; Carton NDC 51754-5001-4), For Intravenous Use Only, RX Only, Manufactured and Distributed by: Exela Pharma Sciences, LLC, Lenoir, NC 28645; ALSO LABELED 8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1mEq/mL), c) 20x50 mL Single Dose Vials, (Vial NDC 72572-740-01; Carton NDC 72572-740-20), Rx Only, Mfd for: Civica, Inc., Lehi, Utah, 84043, Mfd by: Exela Pharma Sciences, LLC, Lenoir, NC 28645.
Where it went: Nationwide
How much: 355,220 vials

Class I

8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials, packaged in cartons of

D-0079-2023 · Class I · reported 2022-12-21 · Terminated

Why it was recalled: Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration.
Product: 8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials, packaged in cartons of 20 vials, Rx only, Manufactured and Distributed by: Exela Pharma Sciences, LLC Lenoir, NC 28645. Carton NDC 51754-5001-5, vial NDC 51754-5001-1.
Where it went: Nationwide within the United States
How much: 489,600 vials

Class I

8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials, packaged in cartons of

D-0022-2023 · Class I · reported 2022-11-02 · Terminated

Why it was recalled: Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration
Product: 8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials, packaged in cartons of 20 vials, Rx only, Manufactured and Distributed by: Exela Pharma Sciences, LLC Lenoir, NC 28645. Carton NDC 51754-5001-5, vial NDC 51754-5001-1
Where it went: Nationwide within the United States
How much: 2,123,040 vials

Sodium Bicarbonate Tablets, 600 mg, 1000-count bottle, MFG: Major Pharma, NDC 0536-1047-10

D-1058-2022 · Class II · reported 2022-06-15 · Terminated

Why it was recalled: cGMP deviations: Temperature abuse
Product: Sodium Bicarbonate Tablets, 600 mg, 1000-count bottle, MFG: Major Pharma, NDC 0536-1047-10
Where it went: USA nationwide.
How much: 1 bottle/1000 tablets per bottle

Read these counts with three things in mind

A firm with more recalls usually makes more products. A contract packer runs hundreds of lines. It will out-recall a company with one product whatever either does. This is not a safety ranking.

Most recalls here are voluntary. A firm found its own fault and pulled the stock. That is the system working. It lands in this database looking the same as a recall the FDA had to push for.

Terminated means the FDA considers the recall finished. It is not a verdict. It does not mean anyone was harmed.

Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.

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