Sodium Bicarbonate recalls

The FDA has published 15 recalls involving Sodium Bicarbonate since 2013. The latest was reported on 17 Sep 2025. Most were for foreign material. 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 recalls15since 2013
Last 12 months0reported
Class I427% of total
Ongoing5latest 17 Sep 2025

Recalls per month, last 24 months

click a bar for that month

Severity split

Class I 4 27%Class II 11 73%Class III 0 0%

Why sodium bicarbonate is recalled

Companies

Brands

By year

Ongoing sodium bicarbonate recalls

5 active
ReportedClassRecallCompanyReasonWhere
DrugCLASS II2% Sodium Bicarbonate Injection, USP, 5 mEq/ 5 mEq/mL) recalledSodium BicarbonateExela Pharma SciencesLead & Heavy MetalsNationwide
DrugCLASS IIVial Label: 4% Sodium Bicarbonate Injection, USP, 50mEq/ (1 mEq/mL) recalledSodium BicarbonatePFIZERSterilityNationwide
DrugCLASS II4% Sodium Bicarbonate Injection, USP, 50 mEq/ (1 mEq/mL) recalledSodium BicarbonateExela Pharma SciencesSterilityNationwide
DrugCLASS I4 % Sodium Bicarbonate Injection, USP 50 mEq/ (1 mEq/mL) recalledSodium BicarbonatePfizerParticulate MatterNationwide
DrugCLASS I4% Sodium Bicarbonate Injection, USP, 50 mEq/ (1mEq/mL) recalledSodium BicarbonateExela Pharma SciencesParticulate MatterNationwide

All sodium bicarbonate recalls, newest first

15 total
ReportedClassRecallCompanyReasonWhere
DrugCLASS II2% Sodium Bicarbonate Injection, USP, 5 mEq/ 5 mEq/mL) recalledSodium BicarbonateExela Pharma SciencesLead & Heavy MetalsNationwide
DrugCLASS IIVial Label: 4% Sodium Bicarbonate Injection, USP, 50mEq/ (1 mEq/mL) recalledSodium BicarbonatePFIZERSterilityNationwide
DrugCLASS II4% Sodium Bicarbonate Injection, USP, 50 mEq/ (1 mEq/mL) recalledSodium BicarbonateExela Pharma SciencesSterilityNationwide
DrugCLASS I4 % Sodium Bicarbonate Injection, USP 50 mEq/ (1 mEq/mL) recalledSodium BicarbonatePfizerParticulate MatterNationwide
DrugCLASS I4% Sodium Bicarbonate Injection, USP, 50 mEq/ (1mEq/mL) recalledSodium BicarbonateExela Pharma SciencesParticulate MatterNationwide
DrugCLASS I4% Sodium Bicarbonate Injection, USP 50 mEq recalledSodium BicarbonateExela Pharma SciencesForeign MaterialNationwide
DrugCLASS I4% Sodium Bicarbonate Injection, USP 50 mEq recalledSodium BicarbonateExela Pharma SciencesForeign MaterialNationwide
DrugCLASS IISodium Bicarbonate Tablets, 600 mg, MFG: Major Pharma recalledSodium Bicarbonate AntacidMckesson Medical-Surgical Inc. Corporate OfficeManufacturing (CGMP) DeviationsNationwide
DrugCLASS IISodium Bicarbonate Tablet, 650 mg, Over The Counter recalledAidapak ServicesLabeling Errors4 states
DrugCLASS IISodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer recalledChurch & DwightForeign MaterialNationwide

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.