Class II · Moderate risk
8.4% Sodium Bicarbonate Injection
Lack of Assurance of Sterility
4.2% Sodium Bicarbonate Injection
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed Impurities/Degradation Specifications: out of specification results for arsenic in the impurities tested.
Cause type: Impurity / degradation
An impurity or degradation product above its limit - other than nitrosamines. Unexpected substances in a batch can make it unsafe or less effective, even when the active ingredient is present. All impurity / degradation recalls.
What was recalled
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)
Affected NDCs
51754-5012-01
51754-5012-04
Compare with the code on your package — it is the most precise check available.
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Sodium Bicarbonate NDC 51754-5012 |
42 mg/mL | Injection, Solution Intravenous |
Exela Pharma Sciences, LLC | Rx |
- Recalling firm
- Exela Pharma Sciences LLC
- NDC code
- 51754-5012-1
- Origin
- NC, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0620-2025 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
Other recalls by Exela Pharma Sciences LLC
All 2025 recalls
Class I · High risk
ELCYS (cysteine hydrochloride injection)
Presence of Particulate Matter: Silicone
Class I · High risk
Midazolam in 0.8% Sodium Chloride Injection 100 mg/100 mL
Presence of Particulate Matter: Silicone
Class I · High risk
8.4% Sodium Bicarbonate Injection
Presence of Particulate Matter: Silicone
Other impurity / degradation recalls from 2025
All impurity / degradation recalls
Class III · Low risk
Fluocinolone Acetonide Solution Topical Solution USP
Failed Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D.
Class III · Low risk
Fesoterodine Fumarate
Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.
Class III · Low risk
Glycopyrrolate Oral Solution
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Ciclopirox Shampoo
Failed Impurity/Degradation specifications: OOS results obtained at the 18-month timepoint
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