4 — Class II drug recall D-0620-2025
Ongoing recall by Exela Pharma Sciences LLC, reported 2025-09-17, distributed nationwide. Failed Impurities/Degradation Specifications: out of specification results for arsenic in the impurities teste
| Recall number | D-0620-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Exela Pharma Sciences LLC, Lenoir, NC, United States |
| Recall initiated | 2025-07-30 |
| Classified | 2025-09-05 |
| Reported by FDA | 2025-09-17 |
| Distributed | Nationwide (US) |
| Reason classes | chemical contamination, specification failure |
| NDC | 51754-5001, 51754-5001-04, 51754-5001-05, 51754-5002, 51754-5002-05, 51754-5011, 51754-5011-04, 51754-5012, 51754-5012-01, 51754-5012-04 |
| Lot numbers | 10004077 |
| Expiration dates | 2026-02-28 |
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 for recall
Failed Impurities/Degradation Specifications: out of specification results for arsenic in the impurities tested.
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-0620-2025. 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.