Unrated Drug recall · FDA · Published March 7, 2025

Exela 8.4% Sodium Bicarbonate Injection Recall: Lack of Sterility Assurance

Exela Pharma Sciences recalls 25 x 50 mL vials of 8.4% Sodium Bicarbonate Injection due to lack of sterility assurance. This injectable medication is for IV use only and requires immediate action to prevent infection risks.

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

🇺🇸 FDA recall #D-0303-2025Drug Exela ›

Recall notice

Lack of Assurance of Sterility

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 8.4% Sodium Bicarbonate Injection vials because they may not be sterile. Using these vials could lead to infections, especially since the product is for intravenous use only. Read more at govinfonow.com/recall/32234-exela-8-4-sodium-bicarbonate-injection-recall-lack-of-sterility.

Source Summary by GovInfoNow · govinfonow.com/recall/32234-exela-8-4-sodium-bicarbonate-injection-recall-lack-of-sterility · Updated August 17, 2026 · FDA enforcement record: FDA #D-0303-2025

Cite this page

“Exela 8.4% Sodium Bicarbonate Injection Recall: Lack of Sterility Assurance.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/32234-exela-8-4-sodium-bicarbonate-injection-recall-lack-of-sterility. Based on FDA recall #D-0303-2025 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0303-2025%22&limit=1).

The FDA announced on March 7, 2025, that Exela Pharma Sciences LLC is voluntarily recalling 8.4% Sodium Bicarbonate Injection due to a lack of assurance of sterility. The agency issued recall number D-0303-2025 for the nationwide distribution of the product.

How to tell if you have it

Brand: Exela
Product: 8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1 mEq/mL), 25 x 50 mL Single Dose Vials per carton
NDC Inner Vial: 51754-5001-1
NDC Carton: 51754-5001-4
Lots: 10006417 and 10006418
Expiration Date: 11/30/2026
Quantity: 103,950 vials

The hazard

The recall is due to a lack of assurance of sterility in the affected lots. The FDA classified this as a Class II recall.

Context

GovInfoNow's records show Exela Pharma Sciences LLC has had seven other recalls since April 20, 2018. Recent similar recalls include an arsenic impurity risk in 4.2% Sodium Bicarbonate Injection on July 30, 2025, and silicone particulate matter hazards in 8.4% Sodium Bicarbonate Injection on Oct. 18, 2023. Other recent recalls of similar products include Fresenius Kabi sodium chloride injections lacking sterility assurance (March 11, 2026) and Huons Co. sodium chloride injection lacking sterility assurance (April 2, 2026).

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), 25 x 50 mL Single Dose Vials per carton'. The NDC numbers 51754-5001-1 (vial) and 51754-5001-4 (carton) with lots 10006417 and 10006418, expiring November 30, 2026.

Brand
Exela
Category
Drug

Based on the official FDA remedy

What to do — step by step

Stop Using Immediately
Discard the vials if you have them, as they may not be sterile and could cause infection.

Where it went and when

Where it was distributed

Distributed nationwide.

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

Distributed nationwide.

Recall timeline

FDA published this recall 26 days after the firm started it.

Mar 7, 2025Firm started the recall
Mar 27, 2025FDA classified it Class II
Apr 2, 2025Published in FDA’s Enforcement Report

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

Similar recalls

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Keep exploring

Link to this recall

<a href="https://govinfonow.com/recall/32234-exela-8-4-sodium-bicarbonate-injection-recall-lack-of-sterility">Exela 8.4% Sodium Bicarbonate Injection Recall: Lack of Sterility Assurance (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-0303-2025 (March 7, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0303-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 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.