CLASS I ONGOING Drug recall · Reported 24 Jan 2024 · FDA Enforcement Report
2% Sodium Bicarbonate Injection, USP 5 mEq/ 5 mEq/mL) recalled by Pfizer
Pfizer is recalling 2% Sodium Bicarbonate Injection, USP 5 mEq/ 5 mEq/mL), Glass Abboject Unit of Use Syringe, distributed nationwide in the US. The recall was initiated on 21 Dec 2023 and the FDA has classified it as Class I.
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-0233-2024
- FDA event ID
- 93681
- Recalling firm
- Pfizer, New York, NY
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 21 Dec 2023
- FDA classified
- 17 Jan 2024
- Reported
- 24 Jan 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Drug class
- Injectable & IV Drugs
Timeline
| 21 Dec 2023 | Recall initiated by company | |
| 17 Jan 2024 | Classified by FDA | +27 days |
| 24 Jan 2024 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Particulate Matter; identified as glass
Product as listed by the FDA
4.2% Sodium Bicarbonate Injection, USP 5 mEq/10 mL (0.5 mEq/mL), Glass ABBOJECT Unit of Use Syringe, For Intravenous Use, Rx Only, 10 mL Syringe per Carton, Hospira, Inc., Lake Forst, IL 60045, NDC 0409-5534-24 (carton), 0409-5534-14 (case).
Where it was distributed
Nationwide in the USA and Puerto Rico.
Questions about this recall
Is 2% Sodium Bicarbonate Injection, USP 5 mEq/ 5 mEq/mL), Glass Abboject Unit of Use Syringe recalled?
Yes. Pfizer recalled 2% Sodium Bicarbonate Injection, USP 5 mEq/ 5 mEq/mL), Glass Abboject Unit of Use Syringe on 21 Dec 2023. The recall is Class I and its status is Ongoing. Recall number D-0233-2024.
Why was it recalled?
Presence of Particulate Matter; identified as glass
Which lots are affected?
Lot GX1542, Exp. 01/01/2025
Where was it sold?
Nationwide in the USA and Puerto Rico.
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 I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
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: 4% Sodium Bicarbonate Injection, USP, 50mEq/ (1 mEq/mL) recalledSodium Bicarbonate | PFIZER | Sterility | Nationwide |
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| Drug | CLASS II | Bicillin L-A (penicllin G benzathine injectable suspension) per-vial recalledBicillin L-a | Pfizer | Particulate Matter | Nationwide |