Sodium Bicarbonate Injection, Solution
FDA Recall NDC 51754-5002

FDA Enforcement Report: View Recall Date, Reasons, and Safety Status

Active & Historical Enforcement Reports

The FDA has identified 5 recorded enforcement report(s) associated with Sodium Bicarbonate (NDC 51754-5002). A significant event, classified as Class II, was initiated on Jul 30, 2025 by Exela Pharma Sciences, Llc. The reported reason for this action was: "Failed Impurities/Degradation Specifications: out of specification results for arsenic in the impurities tested."

This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.

Reported Recall Events

D-0620-2025ONGOINGD-0303-2025ONGOINGD-0116-2024ONGOINGD-0079-2023TERMINATEDD-0022-2023TERMINATED

July 2025 Class II Recall: Failed Impurities/Degradation Specifications

Recall Number
D-0620-2025
Class II Ongoing
Reason for Recall
Failed Impurities/Degradation Specifications: out of specification results for arsenic in the impurities tested.
Initiated
Jul 30, 2025
Reported
Sep 17, 2025
Quantity
N/A

Recall Profile & Regulatory Data

Event ID
97348
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Exela Pharma Sciences LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Product Description
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)
Batch or Lot Expiration Information
Lot# 10004077, Exp. 02/28/2026
Affected Packages Involved in this Recall
51754-5001-5Product
51754-5001-4Product
51754-5011-4Product
51754-5002-5Product
51754-5012-4Product
51754-5012-1Product

March 2025 Class II Recall: Lack of Assurance of Sterility

Recall Number
D-0303-2025
Class II Ongoing
Reason for Recall
Lack of Assurance of Sterility
Initiated
Mar 07, 2025
Reported
Apr 02, 2025
Quantity
103,950 vials

Recall Profile & Regulatory Data

Event ID
96481
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Exela Pharma Sciences LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Product Description
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
Batch or Lot Expiration Information
Lot# Lots: 10006417 and 10006418, Exp. 11/30/2026
Affected Packages Involved in this Recall
51754-5001-5Product
51754-5001-4Product
51754-5011-4Product
51754-5002-5Product
51754-5012-4Product
51754-5001-1Product

October 2023 Class I Recall: Presence of Particulate Matter

Recall Number
D-0116-2024
Class I Ongoing
Reason for Recall
Presence of Particulate Matter: Silicone
Initiated
Oct 18, 2023
Reported
Nov 29, 2023
Quantity
355,220 vials

Recall Profile & Regulatory Data

Event ID
93265
Classification
Class I
Enforcement Status
Ongoing
Recalling Firm
Exela Pharma Sciences LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Product Description
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.
Batch or Lot Expiration Information
Lot# 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
Affected Packages Involved in this Recall
51754-5001-5Product
51754-5001-4Product
51754-5011-4Product
51754-5002-5Product
51754-5012-4Product
51754-5001-1Product
72572-740-01Product
72572-740-20Product

November 2022 Class I Recall: Defective Container

Recall Number
D-0079-2023
Class I Terminated
Reason for Recall
Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration.
Initiated
Nov 28, 2022
Reported
Dec 21, 2022
Quantity
489,600 vials

Recall Profile & Regulatory Data

Event ID
91197
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
Exela Pharma Sciences LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Termination Date
Oct 10, 2025
Product Description
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.
Batch or Lot Expiration Information
Lot# Lots: P0001178 Exp. 05/2023; P0001298, P0001301, P0001313, P0001314, P0001317 Exp. 08/2023; P0001330, P0001464 Exp. 09/2023; P0001442 Exp. 11/2023; P0001467, P0001472, P0001486, P0001532 Exp. 12/2023.
Affected Packages Involved in this Recall
51754-5001-5Product
51754-5001-4Product
51754-5011-4Product
51754-5002-5Product
51754-5012-4Product
51754-5001-1Product

October 2022 Class I Recall: Defective Container

Recall Number
D-0022-2023
Class I Terminated
Reason for Recall
Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration
Initiated
Oct 04, 2022
Reported
Nov 02, 2022
Quantity
2,123,040 vials

Recall Profile & Regulatory Data

Event ID
90956
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
Exela Pharma Sciences LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Termination Date
Oct 10, 2025
Product Description
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
Batch or Lot Expiration Information
Lot# : P0001370, P0001371, P0001372, Exp. 10/2023; P0001433, P0001434 Exp. 11/2023; P0001443, P0001468, P0001469, P0001470, P0001495, P0001505, P0001506, P0001509, P0001510, P0001511, P0001512 Exp. 12/2023; P0001560, P0001561, P0001562, P0001564, P0001566, P0001567, P0001568 Exp. 01/2024; P0001571, P0001572, P0001573, P0001574, P0001578, P0001579, P0001580, P0001583, P0001586, P0001587, P0001588, P0001593, P0001594, P0001610, P0001618, P0001619, P0001654 Exp. 02/2024; P0001644, P0001645, P0001646, P0001662, P0001664 Exp. 03/2024; P0001730 Exp. 05/2024.
Affected Packages Involved in this Recall
51754-5001-5Product
51754-5001-4Product
51754-5011-4Product
51754-5002-5Product
51754-5012-4Product
51754-5001-1Product

About FDA Recall Enforcement Reports

FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.

If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.