8 — Class II drug recall D-0303-2025
Ongoing recall by Exela Pharma Sciences LLC, reported 2025-04-02, distributed nationwide. Lack of Assurance of Sterility
| Recall number | D-0303-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Exela Pharma Sciences LLC, Lenoir, NC, United States |
| Recall initiated | 2025-03-07 |
| Classified | 2025-03-27 |
| Reported by FDA | 2025-04-02 |
| Distributed | Nationwide (US) |
| Quantity | 103,950 vials |
| Reason classes | sterility |
| NDC | 51754-5001, 51754-5001-01, 51754-5001-04, 51754-5001-05, 51754-5002, 51754-5002-05, 51754-5011, 51754-5011-04, 51754-5012, 51754-5012-04 |
| Lot numbers | 10006417, 10006418 |
| Expiration dates | 2026-11-30 |
Product
8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1 mEq/mL), 25 x 50 mL Single Dose Vials per carton, For Intravenous Use Only, Rx Only, Manufactured by: Exela Pharma Sciences, LLC, Lenoir, NC 28645. NDC Inner Vial: 51754-5001-1; NDC Carton: 51754-5001-4
Reason for recall
Lack of Assurance of Sterility
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0303-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.