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)

FDA recall notice · announced September 17, 2025 · Exela Pharma Sciences

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

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)

Reason for recall

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

Notes

Distribution: Nationwide in the USA
Lot/code information: Lot # 10004077, Exp. 02/28/2026
Quantity: N/A
Status: Ongoing
Products in this recall event:
- 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 286 (D-0620-2025)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.