Home / Recalls / Exela Pharma Sciences LLC / D-0620-2025

D-0620-2025 Class II Ongoing

Recalled by Exela Pharma Sciences LLC — Lenoir, NC

FDA drug recall D-0620-2025 was initiated by Exela Pharma Sciences LLC on Jul 30, 2025 and is designated Class II. Reason for recall: Failed Impurities/Degradation Specifications: out of specification results for arsenic in the impurities tested. The recall status is ongoing.

Recall Details

Product Type: Drugs
Report Date: Sep 17, 2025
Initiation Date: Jul 30, 2025
Voluntary/Mandated: Voluntary: Firm initiated

Product Description

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 Pattern

Nationwide in the USA

Code Information

Lot # 10004077, Exp. 02/28/2026

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-0620-2025
openFDA file date: Nov 3, 2026
Loaded by RegDataLab: Nov 4, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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D-0079-2023 Class I — 8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose… (Nov 28, 2022)
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D-0023-2023 Class I — 8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose… (Oct 4, 2022)
D-0369-2022 Class II — 8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL), 50 mL vials, Rx… (Jan 11, 2022)
D-1585-2020 Class III — Potassium Acetate Injection, USP 40 mEq/20 mL (2 mEq/mL) Single Dose Vials, Rx… (May 5, 2020)