CLASS II ONGOING Drug recall · Reported 2 Apr 2025 · FDA Enforcement Report
4% Sodium Bicarbonate Injection, USP, 50 mEq/ (1 mEq/mL) recalled
Exela Pharma Sciences is recalling 4% Sodium Bicarbonate Injection, USP, 50 mEq/ (1 mEq/mL), mL Single Dose Vials per, For, distributed nationwide in the US. The recall was initiated on 7 Mar 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-0303-2025
- FDA event ID
- 96481
- Recalling firm
- Exela Pharma Sciences, Lenoir, NC
- Brand
- Sodium Bicarbonate
- Manufacturer
- Exela Pharma Sciences, LLC
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 7 Mar 2025
- FDA classified
- 27 Mar 2025
- Reported
- 2 Apr 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 7 Mar 2025 | Recall initiated by company | |
| 27 Mar 2025 | Classified by FDA | +20 days |
| 2 Apr 2025 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1 mEq/mL), 25 x 50 mL Single Dose Vials per carton, For Intravenous Use Only, Rx Only, Manufactured by: Exela Pharma Sciences, LLC, Lenoir, NC 28645. NDC Inner Vial: 51754-5001-1; NDC Carton: 51754-5001-4
Where it was distributed
Nationwide
Questions about this recall
Is 4% Sodium Bicarbonate Injection, USP, 50 mEq/ (1 mEq/mL), mL Single Dose Vials per, For recalled?
Yes. Exela Pharma Sciences recalled 4% Sodium Bicarbonate Injection, USP, 50 mEq/ (1 mEq/mL), mL Single Dose Vials per, For on 7 Mar 2025. The recall is Class II and its status is Ongoing. Recall number D-0303-2025.
Why was it recalled?
Lack of Assurance of Sterility
Which lots are affected?
Lots: 10006417 and 10006418, Exp. 11/30/2026
Where was it sold?
Nationwide
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 21 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 | 2% Sodium Bicarbonate Injection, USP, 5 mEq/ 5 mEq/mL) recalledSodium Bicarbonate | Exela Pharma Sciences | Lead & Heavy Metals | Nationwide |
| Drug | CLASS I | Midazolam in 8% Sodium Chloride Injection 100 mg recalled | Exela Pharma Sciences | Particulate Matter | Nationwide |
| Drug | CLASS I | 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 | 4% Sodium Bicarbonate Injection, USP 50 mEq recalledSodium Bicarbonate | Exela Pharma Sciences | Foreign Material | Nationwide |
Other Sodium Bicarbonate recalls
All 15| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | 2% Sodium Bicarbonate Injection, USP, 5 mEq/ 5 mEq/mL) recalledSodium Bicarbonate | Exela Pharma Sciences | Lead & Heavy Metals | Nationwide |
| Drug | CLASS II | Vial Label: 4% Sodium Bicarbonate Injection, USP, 50mEq/ (1 mEq/mL) recalledSodium Bicarbonate | PFIZER | Sterility | Nationwide |
| Drug | CLASS I | 4 % Sodium Bicarbonate Injection, USP 50 mEq/ (1 mEq/mL) recalledSodium Bicarbonate | Pfizer | Particulate Matter | Nationwide |
| Drug | CLASS I | 4% Sodium Bicarbonate Injection, USP, 50 mEq/ (1mEq/mL) recalledSodium Bicarbonate | Exela Pharma Sciences | Particulate Matter | Nationwide |
| Drug | CLASS I | 4% Sodium Bicarbonate Injection, USP 50 mEq recalledSodium Bicarbonate | Exela Pharma Sciences | Foreign Material | Nationwide |