Use caution Drug recall · FDA · Published November 28, 2022

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

Exela Pharma Sciences recalls 50mL sodium bicarbonate vials due to breakage and glass flying when pressurized during administration. Affected vials were packaged in cartons of 20 with specific lot numbers.

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

🇺🇸 FDA recall #D-0080-2023Drug 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 they can break and send glass flying when pressurized during medical use. This hazard could cause serious injury to healthcare workers handling the vials. Read more at govinfonow.com/recall/34212-exela-8-4-sodium-bicarbonate-injection-recall-risk-of-vial.

Source Summary by GovInfoNow · govinfonow.com/recall/34212-exela-8-4-sodium-bicarbonate-injection-recall-risk-of-vial · Updated August 18, 2026 · FDA enforcement record: FDA #D-0080-2023

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/34212-exela-8-4-sodium-bicarbonate-injection-recall-risk-of-vial. Based on FDA recall #D-0080-2023 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0080-2023%22&limit=1).

Exela Pharma Sciences LLC voluntarily recalled 37,320 vials of 8.4% Sodium Bicarbonate Injection due to defective containers that may break and eject glass when pressurized, the FDA said on 2022-11-28.

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: 72572-740-20
Vial NDC: 72572-740-1
Lot: P0001490
Expiration Date: 12/2023
Manufacturer: Exela Pharma Sciences, LLC, Lenoir, NC
Quantity: 37,320 vials

The hazard

The recall addresses complaints of vial breakage and glass flying when the product is pressurized during preparation for administration. The FDA classified this defect as a Class I hazard.

Context

GovInfoNow's records show Exela Pharma Sciences LLC has issued seven other recalls since 2018-04-20. Recent brand recalls include an arsenic impurity risk in 4.2% Sodium Bicarbonate Injection on 2025-07-30 and a lack of sterility assurance in 8.4% Sodium Bicarbonate Injection on 2025-03-07. Other recent recalls of similar products include B. Braun Medical's particulate matter hazard on 2026-08-19, Baxter's fiberglass particulates risk on 2026-08-17, and American Regent's particulate matter risk on 2026-08-11.

How to tell if you have this one

Check for vials labeled '8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose' in cartons of 20. Lot number P0001490 with expiration date 12/2023.

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-0079-2023	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.; Lots: P0001178 Exp. 05/2023; P0001298, P0001301, P0001313, P0001314, P0001317 Exp. 08/2023; P0001330, P0001464 Exp. 09/2023; P0001442 Exp. 11/2023; P0001467, P0001472, P0001486, P0001532 Exp. 12/2023.	489,600 vials	51754-5001-5, 51754-5001-4, 51754-5011-4, 51754-5002-5, 51754-5012-4, 51754-5001-1
D-0080-2023	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: P0001490 Exp. 12/2023	37,320 vials	—

Based on the official FDA remedy

What to do — step by step

Check Vial Condition
Inspect vials for signs of breakage or cracks before use.
Contact Manufacturer
Reach out to Exela Pharma Sciences for specific guidance on handling the vials.

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 2.9 years after the firm started it.

Nov 28, 2022Firm started the recall
Dec 13, 2022FDA classified it Class I
Dec 21, 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.

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Keep exploring

Link to this recall

<a href="https://govinfonow.com/recall/34212-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-0080-2023 (November 28, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0080-2023 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.