CLASS II ONGOING Drug recall · Reported 27 Aug 2025 · FDA Enforcement Report
Vial Label: 4% Sodium Bicarbonate Injection, USP, 50mEq/ (1 mEq/mL) recalled
PFIZER is recalling Vial Label: 4% Sodium Bicarbonate Injection, USP, 50mEq/ (1 mEq/mL), distributed nationwide in the US. The recall was initiated on 4 Aug 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-0591-2025
- FDA event ID
- 97364
- Recalling firm
- PFIZER, New York, NY
- Brand
- Sodium Bicarbonate
- Manufacturer
- Hospira, Inc.
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 4 Aug 2025
- FDA classified
- 18 Aug 2025
- Reported
- 27 Aug 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 4 Aug 2025 | Recall initiated by company | |
| 18 Aug 2025 | Classified by FDA | +14 days |
| 27 Aug 2025 | Published in enforcement report | +9 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
Vial Label: 8.4% Sodium Bicarbonate Injection, USP, 50mEq/50 mL (1 mEq/mL), Rx only, Hospira, Inc., Lake Forest, IL 60045, USA, NDC 0409-6637-24. Case NDC: 00409-6637-14.
Where it was distributed
U.S. Nationwide
Questions about this recall
Is Vial Label: 4% Sodium Bicarbonate Injection, USP, 50mEq/ (1 mEq/mL) recalled?
Yes. PFIZER recalled Vial Label: 4% Sodium Bicarbonate Injection, USP, 50mEq/ (1 mEq/mL) on 4 Aug 2025. The recall is Class II and its status is Ongoing. Recall number D-0591-2025.
Why was it recalled?
Lack of Assurance of Sterility.
Which lots are affected?
Lot #: LH2671, Exp. 11/30/2026
Where was it sold?
U.S. 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 PFIZER
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|---|---|---|---|---|---|
| Drug | CLASS II | Vial Label: Epinephrine Injection, USP, 1mg/ 1 mg/mL) recalled by PFIZER | PFIZER | Sterility | Nationwide |
| Drug | CLASS II | Levoxyl (levothyroxine sodium tablets, USP), 50 mcg recalled by PfizerLevoxyl | Pfizer | Potency & Assay | NY |
| Drug | CLASS II | Bicillin L-A (penicillin G benzathine injectable recalled by PfizerBicillin L-a | Pfizer | Particulate Matter | Nationwide |
| Drug | CLASS II | Bicillin L-A (penicllin G benzathine injectable suspension) per-vial recalledBicillin L-a | Pfizer | Particulate Matter | Nationwide |
| Drug | CLASS II | DOBUTamine Injection, USP, 250 mg/ 5 mg/mL) per Single-dose recalledDobutamine | Pfizer | Other | 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 | 4% Sodium Bicarbonate Injection, USP, 50 mEq/ (1 mEq/mL) recalledSodium Bicarbonate | Exela Pharma Sciences | 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 |