4.2% Sodium Bicarbonate Injection recall — Class II (D-0620-2025) · pharmaranks
Class IIOngoing
4.2% Sodium Bicarbonate Injection recall
FDA recall D-0620-2025 · initiated Jul 30, 2025
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Failed Impurities/Degradation Specifications: out of specification results for arsenic in the impurities tested.
Details
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)
Recalling company
Exela Pharma Sciences LLC
Classification
Class II
Status
Ongoing
Type
Voluntary: Firm initiated
Distribution
Nationwide in the USA
Initiated
Jul 30, 2025
FDA report date
Sep 17, 2025
What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.