CLASS I Drug recall · Reported 1 Feb 2023 · FDA Enforcement Report
Vancomycin Hydrochloride for Injection, USP, Sterile powder recalled
Pfizer is recalling Vancomycin Hydrochloride for Injection, USP, Sterile powder, Single-dose Fliptop Vial, 10, distributed nationwide in the US. The recall was initiated on 22 Dec 2022 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-0184-2023
- FDA event ID
- 91346
- Recalling firm
- Pfizer, New York, NY
- Manufacturer
- Hospira, Inc.
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 22 Dec 2022
- FDA classified
- 25 Jan 2023
- Reported
- 1 Feb 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Particulate Matter
- Drug class
- Antibiotics
Timeline
| 22 Dec 2022 | Recall initiated by company | |
| 25 Jan 2023 | Classified by FDA | +34 days |
| 1 Feb 2023 | 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: Glass particulate matter detected in injectable.
Product as listed by the FDA
Vancomycin Hydrochloride for Injection, USP, 1.5 g/vial, Sterile powder, Single-dose Fliptop Vial, 10 vials per carton, Rx only, Distributed by: Hospira, Inc., Lake Forest, IL 60045. NDC Vial 0409-3515-11; NDC Carton 0409-3515-01
Where it was distributed
USA nationwide and Puerto Rico
Questions about this recall
Is Vancomycin Hydrochloride for Injection, USP, Sterile powder, Single-dose Fliptop Vial, 10 recalled?
Yes. Pfizer recalled Vancomycin Hydrochloride for Injection, USP, Sterile powder, Single-dose Fliptop Vial, 10 on 22 Dec 2022. The recall is Class I and its status is Terminated. Recall number D-0184-2023.
Why was it recalled?
Presence of Particulate Matter: Glass particulate matter detected in injectable.
Which lots are affected?
Lot: 33045BA, EXP 1SEP2023
Where was it sold?
USA nationwide 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.
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|---|---|---|---|---|---|
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| Drug | CLASS II | Bicillin L-A (penicillin G benzathine injectable recalled by PfizerBicillin L-a | Pfizer | Particulate Matter | Nationwide |
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Other Vancomycin recalls
All 20| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Vancomycin Injection, USP in 5% Dextrose per (5 mg/mL) recalledVancomycin Hydrochloride | Baxter Healthcare | Sterility | Nationwide |
| Drug | CLASS II | Vancomycin Injection, USP, in 9% Sodium Chloride recalledVancomycin Hydrochloride | Baxter Healthcare | Sterility | Nationwide |
| Drug | CLASS I | Vancomycin Hydrochloride for Oral Solution, USP, 250 mg recalledVancomycin Hydrochloride | Amneal Pharmaceuticals of New York | Potency & Assay | Nationwide |
| Drug | CLASS II | Vancomycin HCl Oral Solution (PF) 125mg recalled by Edge Pharma | Edge Pharma | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS I | Firvanq (vancomycin hydrochloride for oral solution) recalledFirvanq | Azurity Pharmaceuticals | Packaging Defects | Nationwide |