Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

4.2% Sodium Bicarbonate Injection Recalled by Exela Pharma Sciences LLC Due to Failed Impurities/Degradation Specifications: out of specification results for...

Date: July 30, 2025
Company: Exela Pharma Sciences LLC
Status: Ongoing
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Exela Pharma Sciences LLC directly.

Affected Products

4.2% Sodium Bicarbonate Injection, USP, 5 mEq/10 mL (0.5 mEq/mL), For Intravenous Use Only, 10 mL Single Dose Vial, Rx Only, Manufactured and Distributed by: Exela Pharma Sciences, LLC, Lenoir, NC 28645 USA, NDC 51754-5012-1 (vial); 51754-5012-4 (carton)

Quantity: N/A

Why Was This Recalled?

Failed Impurities/Degradation Specifications: out of specification results for arsenic in the impurities tested.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Exela Pharma Sciences LLC

Exela Pharma Sciences LLC has 12 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report