# FDA recall D-0620-2025

> **Exela Pharma Sciences LLC** · Class II · drug recall initiated 2025-07-30.

## 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.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0620-2025
- **Recalling firm:** Exela Pharma Sciences LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-07-30
- **Report date:** 2025-09-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Lenoir, NC, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0620-2025

## Citation

> AI Analytics. FDA recall D-0620-2025. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/D-0620-2025. Source: US FDA. Licensed CC0.

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