4.2% Sodium Bicarbonate Injection recall
FDA recall D-0620-2025 · initiated Jul 30, 2025
Exela Pharma Sciences LLC recalled 4.2% Sodium Bicarbonate Injection in Jul 2025 — an FDA Class II recall (D-0620-2025) because Failed Impurities/Degradation Specifications: out of specification results for arsenic in the impurities tested.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Failed Impurities/Degradation Specifications: out of specification results for arsenic in the impurities tested.
An impurity above the accepted limit
A by-product of manufacturing or storage exceeded the limit the FDA accepts. Nitrosamines are the common example: the concern is long-term exposure, not immediate danger from one dose.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: N/A
Details
- 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)
- Recalling company
- Exela Pharma Sciences LLC
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA
- Initiated
- Jul 30, 2025
- FDA report date
- Sep 17, 2025
Frequently asked
- Was 4.2% Sodium Bicarbonate Injection recalled?
- Exela Pharma Sciences LLC recalled 4.2% Sodium Bicarbonate Injection in Jul 2025 — an FDA Class II recall (D-0620-2025) because Failed Impurities/Degradation Specifications: out of specification results for arsenic in the impurities tested. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was 4.2% Sodium Bicarbonate Injection recalled?
- Per the FDA enforcement record, the reason for recall D-0620-2025 was: Failed Impurities/Degradation Specifications: out of specification results for arsenic in the impurities tested.
- Is a recalled 4.2% Sodium Bicarbonate Injection dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of 4.2% Sodium Bicarbonate Injection are affected?
- Distributed: Nationwide in the USA. The recall covers these lots — Lot # 10004077, Exp. 02/28/2026. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0620-2025.