Sodium Bicarbonate recalls

Sodium Bicarbonate products have been recalled 8 times, most recently on 17 Sep 2025. The recalling company is usually Exela Pharma Sciences. The most common reason is sterility.

Total recalls8since 2016

Last 12 months0reported

Class I450% of total

Ongoing5latest 17 Sep 2025

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 1Apr 0 0 0Jul 1 1 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 4 50%Class II 3 38%Class III 1 13%

Why sodium bicarbonate is recalled

Companies

Product types

Injectable & IV Drugs788%
Other113%

By year

2025338%
2024113%
2023113%
2022225%
2016113%

Ongoing sodium bicarbonate recalls

5 active

Reported	Class	Recall	Company	Reason	Where
17 Sep 2025Drug	CLASS II	2% Sodium Bicarbonate Injection, USP, 5 mEq/ 5 mEq/mL) recalledSodium Bicarbonate	Exela Pharma Sciences	Lead & Heavy Metals	Nationwide
27 Aug 2025Drug	CLASS II	Vial Label: 4% Sodium Bicarbonate Injection, USP, 50mEq/ (1 mEq/mL) recalledSodium Bicarbonate	PFIZER	Sterility	Nationwide
2 Apr 2025Drug	CLASS II	4% Sodium Bicarbonate Injection, USP, 50 mEq/ (1 mEq/mL) recalledSodium Bicarbonate	Exela Pharma Sciences	Sterility	Nationwide
24 Jan 2024Drug	CLASS I	4 % Sodium Bicarbonate Injection, USP 50 mEq/ (1 mEq/mL) recalledSodium Bicarbonate	Pfizer	Particulate Matter	Nationwide
29 Nov 2023Drug	CLASS I	4% Sodium Bicarbonate Injection, USP, 50 mEq/ (1mEq/mL) recalledSodium Bicarbonate	Exela Pharma Sciences	Particulate Matter	Nationwide

All sodium bicarbonate recalls, newest first

8 total

Reported	Class	Recall	Company	Reason	Where
17 Sep 2025Drug	CLASS II	2% Sodium Bicarbonate Injection, USP, 5 mEq/ 5 mEq/mL) recalledSodium Bicarbonate	Exela Pharma Sciences	Lead & Heavy Metals	Nationwide
27 Aug 2025Drug	CLASS II	Vial Label: 4% Sodium Bicarbonate Injection, USP, 50mEq/ (1 mEq/mL) recalledSodium Bicarbonate	PFIZER	Sterility	Nationwide
2 Apr 2025Drug	CLASS II	4% Sodium Bicarbonate Injection, USP, 50 mEq/ (1 mEq/mL) recalledSodium Bicarbonate	Exela Pharma Sciences	Sterility	Nationwide
24 Jan 2024Drug	CLASS I	4 % Sodium Bicarbonate Injection, USP 50 mEq/ (1 mEq/mL) recalledSodium Bicarbonate	Pfizer	Particulate Matter	Nationwide
29 Nov 2023Drug	CLASS I	4% Sodium Bicarbonate Injection, USP, 50 mEq/ (1mEq/mL) recalledSodium Bicarbonate	Exela Pharma Sciences	Particulate Matter	Nationwide
21 Dec 2022Drug	CLASS I	4% Sodium Bicarbonate Injection, USP 50 mEq recalledSodium Bicarbonate	Exela Pharma Sciences	Foreign Material	Nationwide
2 Nov 2022Drug	CLASS I	4% Sodium Bicarbonate Injection, USP 50 mEq recalledSodium Bicarbonate	Exela Pharma Sciences	Foreign Material	Nationwide
7 Sep 2016Food	CLASS III	Sodium Bicarbonate, Cas # 144-55-8, USP/fcc Grade recalledSodium Bicarbonate	Natrium Products	Other	MI, NJ, RI

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.