Use caution Drug recall · FDA · Published October 4, 2022

Exela 8.4% Sodium Bicarbonate Injection Recall: Risk of Vial Breakage During Use

Exela Pharma Sciences recalls 50mL sodium bicarbonate vials due to reported breakage and glass flying when pressurized during administration preparation. Affected vials have specific lot numbers and expiration dates.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0022-2023Drug Exela ›

Use caution until it’s fixed

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

Take action

Contact the company

Recalling firmExela Pharma Sciences LLC1245 Blowing Rock Blvd · Lenoir, NC 28645-3618

✎ GovInfoNow plain-language explainer

Exela Pharma Sciences is recalling 50mL single-dose sodium bicarbonate injection vials because complaints show they can break and send glass flying when pressurized during preparation. This poses a risk of injury to healthcare workers handling the vials. Read more at govinfonow.com/recall/34306-exela-8-4-sodium-bicarbonate-injection-recall-risk-of-vial.

Source Summary by GovInfoNow · govinfonow.com/recall/34306-exela-8-4-sodium-bicarbonate-injection-recall-risk-of-vial · Updated August 18, 2026 · FDA enforcement record: FDA #D-0022-2023

Cite this page

“Exela 8.4% Sodium Bicarbonate Injection Recall: Risk of Vial Breakage During Use.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/34306-exela-8-4-sodium-bicarbonate-injection-recall-risk-of-vial. Based on FDA recall #D-0022-2023 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0022-2023%22&limit=1).

The FDA announced on Oct. 4, 2022, that Exela Pharma Sciences LLC is recalling 8.4% Sodium Bicarbonate Injection vials due to defective containers that may break and cause glass fragments when pressurized. The recall affects 2,123,040 units distributed nationwide.

How to tell if you have it

Brand: Exela
Product: 8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials
Packaging: Cartons of 20 vials
Carton NDC: 51754-5001-5
Vial NDC: 51754-5001-1
Lot Codes: 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)
Distribution: Nationwide within the United States

The hazard

The FDA reported that complaints were received regarding vial breakage and glass flying when the product is pressurized during preparation for administration. The agency classified this defect as a Class I hazard.

Context

GovInfoNow's records show Exela Pharma Sciences LLC has had 7 other recalls on record since April 20, 2018. Other recent recalls of similar products include an Exela Pharma 4.2% Sodium Bicarbonate Injection recall for arsenic impurity risk (July 30, 2025), an Exela 8.4% Sodium Bicarbonate Injection recall for lack of sterility assurance (March 7, 2025), and an Exela ELCYS injection vial recall for silicone particles in IV fluids (Oct. 18, 2023). Other recent recalls of similar products include a B. Braun Medical 100mL Sodium Chloride Injection recall for particulate matter hazard (Aug. 19, 2026), a Baxter 0.9% Sodium Chloride Injection recall for fiberglass particulates risk (Aug. 17, 2026), and an American Regent Epinephrine Injection recall for particulate matter risk (Aug. 11, 2026).

How to tell if you have this one

Check for vials with the brand name 'Exela' and lot numbers listed in the recall notice: P0001370-P0001594, P0001610, P0001618-P0001619, P0001654, P0001730. The vials are packaged in cartons of 20 and have specific expiration dates.

Brand
Exela
Category
Drug

FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class I
Status
Terminated
Distribution
Nationwide within the United States

Recall number	Product, codes & lots	Quantity	NDC
D-0022-2023	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; 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.	2,123,040 vials	51754-5001-5, 51754-5001-4, 51754-5011-4, 51754-5002-5, 51754-5012-4, 51754-5001-1
D-0023-2023	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, Mfd for: Civica, Inc. Lehi, Utah 84043, Mfd by: Exela Pharma Sciences, LLC, Lenoir, NC 28645, Carton NDC 72572-740-20, vial NDC 72572-740-1.; Lot #: P0001497 Exp. 12/2023; P0001600 Exp. 02/2024; P0001663 Exp. 03/2024	148,920	—

Based on the official FDA remedy

What to do — step by step

Check Vial Lot Number
Look for the lot numbers listed in the recall notice: P0001370 through P0001730.
Stop Using if Affected
If you have a vial with a recalled lot number, stop using it immediately to prevent injury.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Nationwide within the United States” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 3 years after the firm started it.

Oct 4, 2022Firm started the recall
Oct 27, 2022FDA classified it Class I
Nov 2, 2022Published in FDA’s Enforcement Report
Oct 10, 2025FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

Similar recalls

Latest drug recalls

Keep exploring

Link to this recall

<a href="https://govinfonow.com/recall/34306-exela-8-4-sodium-bicarbonate-injection-recall-risk-of-vial">Exela 8.4% Sodium Bicarbonate Injection Recall: Risk of Vial Breakage During Use (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-0022-2023 (October 4, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0022-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.