CLASS II ONGOING Drug recall · Reported 17 Sep 2025 · FDA Enforcement Report
4.2% Sodium Bicarbonate Injection, USP, 5 mEq/ (0.5 mEq/mL) recalled
Exela Pharma Sciences is recalling 4.2% Sodium Bicarbonate Injection, USP, 5 mEq/ (0.5 mEq/mL), For Intravenous Use Only, distributed nationwide in the US. The recall was initiated on 30 Jul 2025 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0620-2025
- FDA event ID
- 97348
- Recalling firm
- Exela Pharma Sciences, Lenoir, NC
- Brand
- Sodium Bicarbonate
- Manufacturer
- Exela Pharma Sciences, LLC
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 30 Jul 2025
- FDA classified
- 5 Sep 2025
- Reported
- 17 Sep 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Lead & Heavy Metals
- Drug class
- Injectable & IV Drugs
Timeline
| 30 Jul 2025 | Recall initiated by company | |
| 5 Sep 2025 | Classified by FDA | +37 days |
| 17 Sep 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Impurities/Degradation Specifications: out of specification results for arsenic in the impurities tested.
Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.
Product as listed by the FDA
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)
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Failed Impurities/Degradation Specifications: out of specification results for arsenic in the impurities tested.
Which lots are affected?
Lot # 10004077, Exp. 02/28/2026
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Exela Pharma Sciences
All 12| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | 8.4% Sodium Bicarbonate Injection, USP, 50 mEq/ (1 mEq/mL) recalledSodium Bicarbonate | Exela Pharma Sciences | Sterility | Nationwide |
| Drug | CLASS I | Midazolam in 0.8% Sodium Chloride Injection 100 mg recalled | Exela Pharma Sciences | Particulate Matter | Nationwide |
| Drug | CLASS I | 8.4% Sodium Bicarbonate Injection, USP, 50 mEq/ (1mEq/mL) recalledSodium Bicarbonate | Exela Pharma Sciences | Particulate Matter | Nationwide |
| Drug | CLASS I | Elcys (cysteine hydrochloride injection), USP, 500 mg recalledElcys | Exela Pharma Sciences | Particulate Matter | Nationwide |
| Drug | CLASS I | 8.4% Sodium Bicarbonate Injection, USP 50 mEq recalledSodium Bicarbonate | Exela Pharma Sciences | Foreign Material | Nationwide |
Other Sodium Bicarbonate recalls
All 34| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Vial Label: 8.4% Sodium Bicarbonate Injection, USP, 50mEq recalledSodium Bicarbonate | Pfizer | Sterility | Nationwide |
| Drug | CLASS II | 8.4% Sodium Bicarbonate Injection, USP, 50 mEq/ (1 mEq/mL) recalledSodium Bicarbonate | Exela Pharma Sciences | Sterility | Nationwide |
| Drug | CLASS I | 8.4 % Sodium Bicarbonate Injection, USP 50 mEq/ (1 mEq/mL) recalledSodium Bicarbonate | Pfizer | Particulate Matter | Nationwide |
| Drug | CLASS I | 4.2% Sodium Bicarbonate Injection, USP 5 mEq/ (0.5 mEq/mL) recalled | Pfizer | Particulate Matter | Nationwide |
| Drug | CLASS I | 8.4% Sodium Bicarbonate Injection, USP, 50 mEq/ (1mEq/mL) recalledSodium Bicarbonate | Exela Pharma Sciences | Particulate Matter | Nationwide |