FDA Drug recall D-0620-2025
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 a…
- FDA Drug
- Class II
- ongoing
- Published 2025-09-17
On 2025-09-17 the FDA classified a Class II recall of 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 a… by Exela Pharma Sciences, citing failed Impurities/Degradation Specifications: out of specification results for arsenic in the impurities tested.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0620-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-07-30 |
| Published | 2025-09-17 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Exela Pharma Sciences |
| Distribution | US |
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
Failed Impurities/Degradation Specifications: out of specification results for arsenic in the impurities tested.
Identifiers
| ndc | 51754-5001-5 |
|---|---|
| ndc | 51754-5001-4 |
| ndc | 51754-5011-4 |
| ndc | 51754-5002-5 |
| ndc | 51754-5012-4 |
| ndc | 51754-5012-1 |
| code_info | Lot # 10004077, Exp. 02/28/2026 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0620-2025%22
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