Exela Pharma 4.2% Sodium Bicarbonate Injection Recall: Arsenic Impurity Risk
Exela Pharma recalls 10mL IV sodium bicarbonate vials with arsenic impurities. This injection for medical use may have unsafe levels of arsenic that could cause harm if used improperly.
Lower-risk recall
Failed Impurities/Degradation Specifications: out of specification results for arsenic in the impurities tested.
Contact the company
What happened, in plain English
Exela Pharma is recalling 10mL single-dose vials of 4.2% sodium bicarbonate injection for IV use due to arsenic impurities. This could pose a health risk if the medication is administered improperly. Read more at govinfonow.com/recall/31939-exela-pharma-4-2-sodium-bicarbonate-injection-recall-arsenic-impurity.
Source Summary by GovInfoNow · govinfonow.com/recall/31939-exela-pharma-4-2-sodium-bicarbonate-injection-recall-arsenic-impurity · Updated August 17, 2026 · FDA enforcement record: FDA #D-0620-2025
Cite this page
“Exela Pharma 4.2% Sodium Bicarbonate Injection Recall: Arsenic Impurity Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/31939-exela-pharma-4-2-sodium-bicarbonate-injection-recall-arsenic-impurity. Based on FDA recall #D-0620-2025 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0620-2025%22&limit=1).
Why it’s dangerous
The injection may contain unsafe levels of arsenic as a contaminant. Arsenic is a toxic substance that could cause harm if the medication is administered improperly.
Who’s affected
Healthcare professionals who use this medication for intravenous treatments. Patients receiving this injection under medical supervision are not directly affected.
How to tell if you have this one
Check for vials labeled '4.2% Sodium Bicarbonate Injection, USP, 5 mEq/10 mL (0.5 mEq/mL), For Intravenous Use Only'. The NDC number 51754-5012-1 (vial) or 51754-5012-4 (carton) with lot number 10004077.
- Brand
Exela Pharma- Category
Drug
What to do — step by step
Check Vial Label
Look for the NDC number 51754-5012-1 (vial) or 51754-5012-4 (carton) with lot number 10004077.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 49 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Questions people ask
Who should stop using this product?
Healthcare professionals who have this product for intravenous use should stop using it until the recall is resolved.
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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-0620-2025 (July 30, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0620-2025 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.