CLASS I Drug recall · Reported 2 Nov 2022 · FDA Enforcement Report

8.4% Sodium Bicarbonate Injection, USP 50 mEq recalled

Exela Pharma Sciences is recalling 8.4% Sodium Bicarbonate Injection, USP 50 mEq/ (1 mEq/mL) Single Dose Vials, distributed nationwide in the US. The recall was initiated on 4 Oct 2022 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesLot # : 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.

NDC51754-5001, 51754-5011, 51754-5002, 51754-5012

Quantity recalled2,123,040 vials

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-0022-2023
FDA event ID: 90956
Recalling firm: Exela Pharma Sciences, Lenoir, NC
Brand: Sodium Bicarbonate
Manufacturer: Exela Pharma Sciences, LLC
Classification: Class I
Status: Terminated
Recall initiated: 4 Oct 2022
FDA classified: 27 Oct 2022
Reported: 2 Nov 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Foreign Material
Drug class: Injectable & IV Drugs

Timeline

4 Oct 2022	Recall initiated by company
27 Oct 2022	Classified by FDA	+23 days
2 Nov 2022	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration

Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.

Product as listed by the FDA

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

Where it was distributed

Nationwide within the United States

Nationwide

Questions about this recall

Why was it recalled?

Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration

Which lots are affected?

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.

Where was it sold?

Nationwide within the United States

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 90956

Reported	Class	Recall	Company	Reason	Where
2 Nov 2022	CLASS I	8.4% Sodium Bicarbonate Injection, USP 50 mEq recalled	Exela Pharma Sciences	Foreign Material	Nationwide

More recalls from Exela Pharma Sciences

All 12

Reported	Class	Recall	Company	Reason	Where
17 Sep 2025Drug	CLASS II	4.2% Sodium Bicarbonate Injection, USP, 5 mEq/ (0.5 mEq/mL) recalledSodium Bicarbonate	Exela Pharma Sciences	Lead & Heavy Metals	Nationwide
2 Apr 2025Drug	CLASS II	8.4% Sodium Bicarbonate Injection, USP, 50 mEq/ (1 mEq/mL) recalledSodium Bicarbonate	Exela Pharma Sciences	Sterility	Nationwide
29 Nov 2023Drug	CLASS I	Midazolam in 0.8% Sodium Chloride Injection 100 mg recalled	Exela Pharma Sciences	Particulate Matter	Nationwide
29 Nov 2023Drug	CLASS I	8.4% Sodium Bicarbonate Injection, USP, 50 mEq/ (1mEq/mL) recalledSodium Bicarbonate	Exela Pharma Sciences	Particulate Matter	Nationwide
29 Nov 2023Drug	CLASS I	Elcys (cysteine hydrochloride injection), USP, 500 mg recalledElcys	Exela Pharma Sciences	Particulate Matter	Nationwide

Other Sodium Bicarbonate recalls

All 34

Reported	Class	Recall	Company	Reason	Where
17 Sep 2025Drug	CLASS II	4.2% Sodium Bicarbonate Injection, USP, 5 mEq/ (0.5 mEq/mL) recalledSodium Bicarbonate	Exela Pharma Sciences	Lead & Heavy Metals	Nationwide
27 Aug 2025Drug	CLASS II	Vial Label: 8.4% Sodium Bicarbonate Injection, USP, 50mEq recalledSodium Bicarbonate	Pfizer	Sterility	Nationwide
2 Apr 2025Drug	CLASS II	8.4% Sodium Bicarbonate Injection, USP, 50 mEq/ (1 mEq/mL) recalledSodium Bicarbonate	Exela Pharma Sciences	Sterility	Nationwide
24 Jan 2024Drug	CLASS I	8.4 % Sodium Bicarbonate Injection, USP 50 mEq/ (1 mEq/mL) recalledSodium Bicarbonate	Pfizer	Particulate Matter	Nationwide
24 Jan 2024Drug	CLASS I	4.2% Sodium Bicarbonate Injection, USP 5 mEq/ (0.5 mEq/mL) recalled	Pfizer	Particulate Matter	Nationwide