Drug FDA Class II Ongoing Failed specifications
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)
Exela Pharma Sciences LLC Published Sep 17, 2025
Risk level
Class IIMay cause a temporary or reversible health problem; slight chance of serious harm.
Severity score 60/100
What should you do?
- Check whether you have this product, using the lot codes, UPCs, and dates listed below.
- Do not eat, serve, or sell the affected product.
- Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
- Contact Exela Pharma Sciences LLC or your place of purchase with questions, and see the source record below for full details.
Reason for recall
Failed Impurities/Degradation Specifications: out of specification results for arsenic in the impurities tested.
Hazards
Arsenic · primary
Affected products (1)
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)
SODIUM BICARBONATE · N/A
NDC: 51754-5001, 51754-5011, 51754-5002, 51754-5012, 51754-5001-5, 51754-5001-4, 51754-5011-4, 51754-5002-5, 51754-5012-4, 51754-5012-1
Lot codes: 10004077
Code info: Lot # 10004077, Exp. 02/28/2026
Affected areas
Nationwide
Timeline
- InitiatedJul 30, 2025
- PublishedSep 17, 2025
- Recall number
- D-0620-2025
- Agency
- U.S. Food and Drug Administration
- Country
- US
FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.