Sodium Bicarbonate
FDA Recall NDC 0409-4916
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.
The FDA has identified 2 recorded enforcement report(s) associated with Sodium Bicarbonate (NDC 0409-4916). A significant event, classified as Class II, was initiated on Aug 04, 2025 by Hospira, Inc.. The reported reason for this action was: "Lack of Assurance of Sterility."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
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
Class II Ongoing
Lack of Assurance of Sterility.
Aug 04, 2025
Aug 27, 2025
15,750 vials
Recall Profile & Regulatory Data
Event ID
97364
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
PFIZER INC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S. Nationwide
Product Description
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.
Batch or Lot Expiration Information
Lot# : LH2671, Exp. 11/30/2026
Affected Packages Involved in this Recall
0409-4916-24Product
0409-4916-14Product
0409-6637-24Product
0409-6637-14Product
00409-6637-14Product
December 2023 Class I Recall: Presence of Particulate Matter; identified as glass
Recall Number
Class I Ongoing
Presence of Particulate Matter; identified as glass
Dec 21, 2023
Jan 24, 2024
21200 Cartons
Recall Profile & Regulatory Data
Event ID
93681
Classification
Class I
Enforcement Status
Ongoing
Recalling Firm
Pfizer Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA and Puerto Rico.
Product Description
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).
Batch or Lot Expiration Information
Lot# Lot HA7295, EXP 03/01/2025
Affected Packages Involved in this Recall
0409-4916-24Product
0409-4916-14Product
0409-6637-24Product
0409-6637-14Product
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.
