Agency classClass IIOur severity:High FDA (Drugs)·D-0620-2025·Announced 2025-09-17

Sodium bicarbonate injection recalled after arsenic exceeded impurity specification

Exela 4.2% Sodium Bicarbonate Injection USP, 5 mEq/10 mL, lot 10004077, is recalled nationwide after out-of-specification results for arsenic in impurities testing.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Rubric level 3 covers risk-of-harm products where injury has not yet been reported; an injectable medicine with arsenic above its impurity specification is a potential harm and no injuries are reported.

Plain-English summary

4.2% Sodium Bicarbonate Injection, USP, 5 mEq/10 mL (0.5 mEq/mL), for intravenous use only in 10 mL single dose vials, manufactured and distributed by Exela Pharma Sciences, LLC of Lenoir, North Carolina, NDC 51754-5012-1 for the vial and 51754-5012-4 for the carton, is being recalled. The affected product is lot 10004077 with an expiry of 02/28/2026, distributed nationwide.

The recall was issued because the product failed impurities and degradation specifications, with out-of-specification results for arsenic in the impurities tested. The FDA classified the action as Class II.

Hospitals and pharmacies holding this lot should quarantine it, stop using it, and follow the manufacturer's instructions for return or replacement.

The recalled product

Product: SODIUM BICARBONATE (SODIUM BICARBONATE)
Brand: SODIUM BICARBONATE
Manufacturer: Exela Pharma Sciences LLC
Category: Drug — Injectable
Hazard: failed-specification
impurity
arsenic
class-ii

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

Lot # 10004077
Exp. 02/28/2026

Distribution

Distributed nationwide across the United States.

Same brand · SODIUM BICARBONATE

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FDA Recalls Sodium Bicarbonate Injection for Defective Vials
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Same manufacturer · Exela Pharma Sciences LLC

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Same hazard · failed specification