Sodium Bicarbonate is a prescription medicine. The sections below reproduce one FDA label for it, named under "Label". Products in other forms, strengths or from other makers have their own labels, which can differ.
On the FDA shortage list — 4 products are unavailable or in limited supply. Which forms
- Type
- Prescription only (Rx)
- Taken
- Intravenous
- Label
- Baxter Healthcare Corporation, revised August 14, 2026 · full label on DailyMed
- Generic
- FDA-approved (11 companies) · details
What it is used for
Sodium bicarbonate injection is an alkalinizing agent indicated:
- to raise plasma pH in adult and pediatric patients with clinically significant metabolic acidosis. ( 1.1 )
- to alkalinize the urine in drug poisoning in adult and pediatric patients in cases in which urinary drug elimination is enhanced by urinary alkalinaztion. ( 1.2 ) Limitation of Use Do not use sodium bicarbonate injection in settings where rapid administration of sodium bicarbonate is required, such as cardiac arrest. In such situations use a more concentrated solution.
1.1 Treatment of Clinically Significant Metabolic Acidosis Sodium bicarbonate injection is indicated to raise plasma pH in adult and pediatric patients with clinically significant metabolic acidosis.
1.2 Urinary Alkalization in Drug Poisoning Sodium bicarbonate injection is indicated to alkalinize the urine in drug poisoning in adult and pediatric patients in cases in which urinary drug elimination is enhanced by urinary alkalinaztion. Limitation of Use Do not use sodium bicarbonate injection in settings where rapid administration of sodium bicarbonate is required, such as cardiac arrest. In such situations use a more concentrated solution.
Forms and strengths
Sodium Bicarbonate Injection is a clear, colorless, sterile, nonpyrogenic, isotonic solution intended for intravenous use and available as: Injection: 12.6 mg/mL (0.150 mEq/mL), 12,600 mg of sodium bicarbonate injection in 1,000 mL single-dose Viaflo container Injection: 12.6 mg/mL (0.150 mEq/mL), 12,600 mg of Sodium Bicarbonate Injection in 1,000 mL single-dose Viaflo container. ( 3 )
Who should not take it (contraindications)
Sodium bicarbonate injection is contraindicated in patients who are losing chloride by vomiting or from continuous gastrointestinal suction and in patients receiving diuretics known to produce a hypochloremic alkalosis. Sodium bicarbonate injection is contraindicated in patients who are losing chloride by vomiting or from continuous gastrointestinal suction and in patients receiving diuretics known to produce a hypochloremic alkalosis. ( 4 )
Warnings and precautions
- Edema with Sodium Retention: Monitor patients who are sensitive to sodium intake (heart failure, hypertension, kidney disease, anuria, edema) for signs of fluid overload and adjust as appropriate. ( 5.1 )
- Electrolyte Imbalances: Therapy with sodium bicarbonate injection can result in metabolic alkalosis (associated with muscular twitchings, irritability and tetany) and hypernatremia. Monitor electrolytes periodically during administration and treat abnormalities appropriately. Dosing with sodium bicarbonate injection results in a large volume of administration in younger and lighter weight pediatric patients. Consider use of more concentrated sodium bicarbonate formulations in these pediatric populations. ( 5.2 )
- Extravasation: Prompt elevation of the area, warmth, and local injection of lidocaine or hyaluronidase are recommended to reduce the likelihood of tissue sloughing at the site. ( 5.3 )
5.1 Edema with Sodium Retention Sodium bicarbonate injection can cause sodium retention and volume overload. Monitor patients who are sensitive to sodium intake (heart failure, hypertension, kidney disease, anuria, edema) for signs of fluid overload and adjust sources of sodium as appropriate.
5.2 Electrolyte Imbalances Sodium bicarbonate injection may cause electrolyte imbalances. Overly aggressive therapy with sodium bicarbonate injection can result in metabolic alkalosis (associated with muscular twitchings, irritability and tetany) and hypernatremia. Monitor electrolytes periodically during administration and treat abnormalities appropriately. Dosing with sodium bicarbonate injection results in a large volume of administration in younger and lighter weight pediatric patients. Consider use of more concentrated sodium bicarbonate formulations in these pediatric populations [see Dosing and Administration (2) ].
5.3 Extravasation Inadvertent extravasation of intravenously administered hypertonic solutions of sodium bicarbonate have been reported to cause chemical cellulitis because of their alkalinity, with tissue necrosis, ulceration or sloughing at the site of infiltration. Prompt elevation of the area, warmth, and local injection of lidocaine or hyaluronidase are recommended to reduce the likelihood of tissue sloughing at the site of intravenous solution extravasation.
Side effects (adverse reactions)
The following clinically significant adverse reactions are described elsewhere in labeling:
- Edema with Sodium Retention [see Warnings and Precautions (5.1) ]
- Electrolyte Imbalances [see Warnings and Precautions (5.2) ]
- Extravasation [see Warnings and Precautions (5.3) ] Adverse reactions include edema with sodium retention, electrolyte imbalances and extravasation. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Baxter Healthcare Corporation at 1-877-725-2747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Pregnancy, breastfeeding, children and older adults
- Pediatric Use: Rapid injection in neonates and children under two years of age may produce hypernatremia, a decrease in cerebrospinal fluid pressure and possible intracranial hemorrhage. ( 8.4 )
8.1 Pregnancy Risk Summary Available data from published literature over decades of use have not identified a drug associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. Physiological replacement of sodium bicarbonate is not expected to lead to increased risk of adverse fetal or maternal outcomes. Animal reproduction studies have not been conducted with sodium bicarbonate. The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
8.2 Lactation Risk Summary There are no data on the presence of sodium bicarbonate in either human or animal milk, the effects on the breast-fed infant or the effects on milk production following administration of sodium bicarbonate injection. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for sodium bicarbonate injection and any potential adverse effects on the breast-fed child from sodium bicarbonate or from the underlying maternal condition.
8.4 Pediatric Use Sodium bicarbonate injection is indicated in pediatric patients:
- To raise plasma pH in pediatric patients with clinically significant metabolic acidosis
- To alkalinize the urine in drug poisoning in cases in which urinary drug elimination is enhanced by urinary alkalinization Rapid injection of sodium bicarbonate injection solutions into neonates and children under two years of age may produce hypernatremia, a decrease in cerebrospinal fluid pressure and possible intracranial hemorrhage. The rate of administration in such patients should therefore be limited to no more than 8 mEq/kg/day.
8.5 Geriatric Use Clinical studies of sodium bicarbonate injection did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.
How it works
Intravenous sodium bicarbonate therapy increases plasma bicarbonate, buffers excess hydrogen ion concentration, raises blood pH.
Is there a generic Sodium Bicarbonate?
Yes. The FDA has approved generic Sodium Bicarbonate from 11 companies whose approvals are active. The earliest of these was approved in 2016.
An FDA approval does not always mean the generic is already in pharmacies: patent disputes and settlements can delay a launch for years. Your pharmacist can tell you whether a generic is actually available and covered by your plan.
The FDA rates these generics as therapeutically equivalent to the brand ("A" rating): same active ingredient, strength, dosage form and effect. Pharmacists can usually substitute them unless the prescriber says otherwise.
Companies with an approved generic
Amneal, Anthea Pharma, Aspiro, Exela Pharma, Fresenius Kabi Usa, Hospira, Intl Medication Sys, Long Grove Pharms, Milla Pharms, Omnivium Pharms, Steriscience
Brand-name versions
- Sodium Bicarbonate In Plastic Container Abbott, approved 1986 Discontinued
Source: Drugs@FDA (via openFDA), checked October 29, 2026. Marketing status is what companies report to the FDA; whether a pharmacy stocks a product, and what your insurance covers, can differ.
Dosage:
we do not reproduce dosing instructions. The right dose depends on the person and the condition and is set by the prescriber or pharmacist. Dosage section of the full label.
Sodium bicarbonate in the news
We have not covered this medicine yet. Latest news
Shortage status
| Product | Availability | Expected supply / notes |
|---|---|---|
| Sodium Bicarbonate, Injection, 50 mEq/50 mL (8.4%, 1 mEq/mL) (NDC 0409-6625-35) Hospira, Inc., a Pfizer Company |
Unavailable | Next Delivery and Estimated Recovery: June 2027; Shortage per Manufacturer: Manufacturing Delay In shortage · October 21, 2026 |
| Sodium Bicarbonate, Injection, 2.5 mEq/5 mL (4.2%, 0.5 mEq/mL) (NDC 0409-5555-02) Hospira, Inc., a Pfizer Company |
Limited | Limited Supply Available. Next Delivery: February 2027; Estimated Recovery: March 2027 In shortage · October 21, 2026 |
| Sodium Bicarbonate, Injection, 2.5 mEq/5 mL (4.2%, 0.5 mEq/mL) (NDC 0409-5555-01) Hospira, Inc., a Pfizer Company |
Limited | Limited Supply Available. Next Delivery and Estimated Recovery: June 2027; Shortage per Manufacturer: Manufacturing Delay In shortage · October 21, 2026 |
| Sodium Bicarbonate, Injection, 84 mg/1 mL (NDC 76329-3352-1) Amphastar Pharmaceuticals, Inc. |
Limited | Available on allocation In shortage · October 16, 2026 |
| Sodium Bicarbonate, Injection, 50 mEq/50 mL (8.4%, 1 mEq/mL) (NDC 0409-6625-14) Hospira, Inc., a Pfizer Company |
Available | — In shortage · October 21, 2026 |
| Sodium Bicarbonate, Injection, 84 mg/1 mL (NDC 81298-7620-3) Long Grove Pharmaceuticals LLC |
Available | — In shortage · October 16, 2026 |
| Sodium Bicarbonate, Injection, 42 mg/1 mL (NDC 51754-5012-4) Exela Pharma Sciences, LLC |
Available | — In shortage · October 15, 2026 |
| Sodium Bicarbonate, Injection, 84 mg/1 mL (NDC 51754-5001-5) Exela Pharma Sciences, LLC |
Available | — In shortage · October 15, 2026 |
| Sodium Bicarbonate, Injection, 42 mg/1 mL (NDC 63323-083-05) Fresenius Kabi USA, LLC |
Available | Check wholesalers for inventory. In shortage · October 15, 2026 |
| Sodium Bicarbonate, Injection, 84 mg/1 mL (NDC 51754-5011-4) Exela Pharma Sciences, LLC |
Available | — In shortage · October 15, 2026 |
| Sodium Bicarbonate, Injection, 84 mg/1 mL (NDC 63323-089-50) Fresenius Kabi USA, LLC |
Available | Check wholesalers for inventory In shortage · October 15, 2026 |
| Sodium Bicarbonate, Injection, 84 mg/1 mL (NDC 0409-4900-14) Hospira, Inc., a Pfizer Company |
Discontinuation of the manufacture of the drug Being discontinued · November 7, 2025 |
|
| Sodium Bicarbonate, Injection, 42 mg/1 mL (NDC 0409-5534-14) Hospira, Inc., a Pfizer Company |
Discontinuation of the manufacture of the drug Being discontinued · November 7, 2025 |
|
| Sodium Bicarbonate, Injection, 75 mg/1 mL (NDC 0409-4916-14) Hospira, Inc., a Pfizer Company |
Discontinuation of the manufacture of the drug Being discontinued · November 7, 2025 |
|
| Sodium Bicarbonate, Injection, 84 mg/1 mL (NDC 0409-6637-14) Hospira, Inc., a Pfizer Company |
Discontinuation of the manufacture of the drug Being discontinued · November 7, 2025 |
Recalls
-
Class II Ongoing
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 51754-50…
Reason: Failed Impurities/Degradation Specifications: out of specification results for arsenic in the impurities tested.
Lots, distribution and details
- 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)
- Lots / codes
- Lot # 10004077, Exp. 02/28/2026
- Distribution
- Nationwide in the USA
- Quantity
- N/A
- Recall started
- July 30, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0620-2025
-
Class II Ongoing
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.
Reason: Lack of Assurance of Sterility.
Lots, distribution and details
- 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.
- Lots / codes
- Lot #: LH2671, Exp. 11/30/2026
- Distribution
- U.S. Nationwide
- Quantity
- 15,750 vials
- Recall started
- August 4, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0591-2025
-
Class II Ongoing
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:…
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- 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
- Lots / codes
- Lots: 10006417 and 10006418, Exp. 11/30/2026
- Distribution
- Nationwide
- Quantity
- 103,950 vials
- Recall started
- March 7, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0303-2025
-
Class I Ongoing
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), 0409-66…
Reason: Presence of Particulate Matter; identified as glass
Lots, distribution and details
- 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).
- Lots / codes
- Lot HA7295, EXP 03/01/2025
- Distribution
- Nationwide in the USA and Puerto Rico.
- Quantity
- 21200 Cartons
- Recall started
- December 21, 2023 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0234-2024
-
Class I Ongoing
4.2% Sodium Bicarbonate Injection, USP 5 mEq/10 mL (0.5 mEq/mL), Glass ABBOJECT Unit of Use Syringe, For Intravenous Use, Rx Only, 10 mL Syringe per Carton, Hospira, Inc., Lake Forst, IL 60045, NDC 0409-5534-24 (carton),…
Reason: Presence of Particulate Matter; identified as glass
Lots, distribution and details
- Product
- 4.2% Sodium Bicarbonate Injection, USP 5 mEq/10 mL (0.5 mEq/mL), Glass ABBOJECT Unit of Use Syringe, For Intravenous Use, Rx Only, 10 mL Syringe per Carton, Hospira, Inc., Lake Forst, IL 60045, NDC 0409-5534-24 (carton), 0409-5534-14 (case).
- Lots / codes
- Lot GX1542, Exp. 01/01/2025
- Distribution
- Nationwide in the USA and Puerto Rico.
- Quantity
- 34000 Cartons
- Recall started
- December 21, 2023 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0233-2024
-
Class I Ongoing
8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1mEq/mL), a) 20×50 mL Single Dose Vials (Vial NDC 51754-5001-1; Carton NDC 51754-5001-5) and b) 25×50 mL Single Dose Vials (Vial NDC 51754-5001-1; Carton NDC 51754-50…
Reason: Presence of Particulate Matter: Silicone
Lots, distribution and details
- Product
- 8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1mEq/mL), a) 20×50 mL Single Dose Vials (Vial NDC 51754-5001-1; Carton NDC 51754-5001-5) and b) 25×50 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) 20×50 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.
- Lots / codes
- a) P0001429, EXP 11/30/2023 b) P0001900, P0001902, EXP 08/31/2024; P0001903, P0001909, P0001945, EXP 09/30/2024; P0002002, EXP 11/30/2024; P0002052, EXP 12/31/2024 c) P0001912, EXP 08/31/2024
- Distribution
- Nationwide
- Quantity
- 355,220 vials
- Recall started
- October 18, 2023 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0116-2024
-
Class I Terminated
4.2% Sodium Bicarbonate Injection, USP 5 mEq/10 mL (0.5mEq/mL), Glass ABBOJECT Unit of Use Syringe, packaged as 1 vial and injector per carton, Rx only, Hospira Inc., Lake Forest, IL 60045, NDC 0409-5534-24
Reason: Presence of Particulate Matter: identified as glass.
Lots, distribution and details
- Lots / codes
- Lot#: GJ5007, Exp. 8/1/2024
- Distribution
- Nationwide in the US and Puerto Rico. The products were not distributed to government accounts or foreign consignees.
- Quantity
- 24,900 vials
- Recall started
- October 2, 2023 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0100-2024
-
Class I Ongoing
8.4% Sodium Bicarbonate Injection, USP 50mEq (1mEq/mL), 4.2 grams (84 mg/mL), 50 mL, Rx only, Hospira Inc, Lake Forest, IL 60045, NDC 0409-6625-02
Reason: Presence of Particulate Matter: particulate matter identified as an insect in one vial.
Lots, distribution and details
- Lots / codes
- Lot # 56-148-EV, Exp 8/1/2017
- Distribution
- Nationwide
- Quantity
- 72,000 units
- Recall started
- March 18, 2016 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0865-2016
Have this medicine at home? Compare the lot number and expiry date on your package with the recall. Do not stop taking a prescribed medicine on your own — stopping suddenly can be riskier than the recalled lot. Your pharmacist can check it and usually swap it for an unaffected one.
Get alerts for Sodium Bicarbonate
We will email you if the FDA reports a recall, if its shortage status changes, or when we publish news about it — at most one email a day. No account needed.
Source: FDA structured product labeling, retrieved through openFDA. Label text is shown as published by the FDA, without editing; long sections are shortened, marked […]. openFDA data are not validated for clinical use — always check the current label and ask a doctor or pharmacist about your own treatment. Set ID b50c858a-00c8-4cb2-ad73-8797f19e656d.