Quick Facts at a Glance
- Recall Date
- July 30, 2025
- Hazard Level
- HIGH
- Brands
- SODIUM BICARBONATE, Exela Pharma Sciences
- Category
- Health & Personal Care
- Sold At
- Unknown
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL, PREGNANT, PETS
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- SODIUM BICARBONATE, Exela Pharma Sciences
- Product type
- Intravenous Sodium Bicarbonate Injection
- Model numbers
- Lot # 10004077, Exp. 02/28/2026
- UPC codes
- 51754-5001, 51754-5011, 51754-5002, 51754-5012, 51754-5001-5, 51754-5001-4, 51754-5011-4, 51754-5002-5 +2 more
- Sizes
- 10 mL single-dose vial
- Sold at
- Unknown
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
July 30, 2025
Reported by FDA DRUG
September 17, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Failed Impurities/Degradation Specifications: out of specification results for arsenic in the impurities tested.
What You Should Do
Consumers and healthcare providers should stop using this product immediately. Contact Exela Pharma Sciences LLC or your healthcare provider for guidance. Notification method: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
About This Product
IV sodium bicarbonate injection used to treat acid-base disorders and metabolic acidosis in hospitalized patients.
Why This Is Dangerous
Arsenic impurities in impurities tested may pose serious safety risks if administered intravenously.
Industry Context
This recall is not clearly described as part of a broader industry pattern.
Real-World Impact
Immediate discontinuation advised. Potential safety risk to patients receiving IV treatment.
Practical Guidance
How to identify if yours is affected
- Confirm Lot # 10004077 and Expiration 02/28/2026.
- Verify packaging shows Exela Pharma Sciences, Lenoir, NC.
Where to find product info
FDA enforcement report linked in recall notice for full scope.
What timeline to expect
Consumers should expect recall communications and guidance to be issued within days; replacement or refund processes follow company notification.
If the manufacturer is unresponsive
- Contact FDA for guidance.
- File a consumer safety complaint if the company is unresponsive.
How to prevent similar issues
- Always verify NDCs before administration.
- Ensure hospital inventory management flags recalled lots.
- Coordinate with suppliers for recalls and replacements.
Documentation advice
Keep copy of recall notification, NDCs, lot number, expiration date, and correspondence with manufacturer.
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Product Details
Product: 4.2% Sodium Bicarbonate Injection, USP, 5 mEq/10 mL (0.5 mEq/mL). Form: 10 mL single-dose vial. Type: Intravenous use only. Rx only. Manufactured and distributed by Exela Pharma Sciences, LLC, Lenoir, NC 28645 USA. NDC: 51754-5012-1 (vial); 51754-5012-4 (carton). Sold nationwide in the USA. Lot: 10004077. Expiration: 02/28/2026.
Reported Incidents
No specific patient injury or incident counts are provided in the notice. The status remains ACTIVE and classified as HIGH hazard.
Key Facts
- HIGH hazard level
- Arsenic impurity out-of-specification
- Nationwide distribution in USA
Browse More Recalls
Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
Read: What to Do When You Find a Recalled ProductGet Alerts for Health & Personal Care Recalls
Get instant alerts for recalls that affect you. Free forever.
