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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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High RiskFDA Drug
Medications & Supplements/Prescription Drugs

Sodium Bicarbonate Injection Recalled for Lack of Sterility Assurance

Agency Publication Date: March 27, 2025
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Summary

Exela Pharma Sciences LLC is recalling approximately 103,950 vials of 8.4% Sodium Bicarbonate Injection, USP (50 mEq/50 mL). This recall was issued because the company cannot guarantee the sterility of the product, which is intended for intravenous use. If you have been treated with this medication, you should contact your healthcare provider or pharmacist immediately to discuss any concerns.

Risk

Injecting a product that is not sterile can result in serious or life-threatening systemic infections, such as sepsis or meningitis. The risk is particularly high for patients who are already hospitalized or have weakened immune systems.

What You Should Do

  1. This recall affects 8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1 mEq/mL) sold in cartons of 25 single-dose vials under lots 10006417 and 10006418 with an expiration date of 11/30/2026.
  2. Identify affected products by checking the NDC codes: 51754-5001-1 (inner vial) or 51754-5001-4 (carton).
  3. Stop using the recalled product immediately.
  4. Contact Exela Pharma Sciences LLC or your medical distributor to arrange for the return of any remaining stock.
  5. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for more information.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: 8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1 mEq/mL)
Variants: 50 mEq/50 mL, 1 mEq/mL, Single Dose Vial, 25 vials per carton
Lot Numbers:
10006417 (Exp. 11/30/2026)
10006418 (Exp. 11/30/2026)
NDC:
51754-5001-1
51754-5001-4

Intravenous use only. Rx Only. Manufactured in Lenoir, NC.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96481
Status: Active
Manufacturer: Exela Pharma Sciences LLC
Manufactured In: United States
Units Affected: 103,950 vials
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.