Sodium Bicarbonate Injection Recall: Exela 10004077
Announced 2025-09-17 · FDA
Exela Pharma Sciences LLC is recalling 4.2% Sodium Bicarbonate Injection, USP, 10 mL single-dose vials. The recall is due to failed impurities/degradation specifications with arsenic detected in the impurities tested. Distribution was nationwide in the USA; Lot # 10004077, Exp. 02/28/2026.
| Brand | Exela Pharma Sciences LLC |
|---|---|
| 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. |
| Severity | moderate |
| Units affected | N/A |
| Distribution | Nationwide in the USA |
| Agency | FDA |
| Recall / campaign no. | Lot # 10004077, Exp. 02/28/2026 |
WHAT YOU SHOULD DO
- Do not use this recalled product.
- If you have the recalled lot, contact your healthcare provider or pharmacist for disposal or replacement guidance.
- Check with your pharmacy or the manufacturer for instructions on returning the product and obtaining a safe substitute.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.