CLASS I Drug recall · Reported 21 Sep 2022 · FDA Enforcement Report
Propofol Injectable Emulsion (10 mg/mL) recalled by Pfizer
Pfizer is recalling Propofol Injectable Emulsion (10 mg/mL), distributed nationwide in the US. The recall was initiated on 22 Aug 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-1540-2022
- FDA event ID
- 90785
- Recalling firm
- Pfizer, New York, NY
- Brand
- Propofol
- Manufacturer
- Hospira, Inc.
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 22 Aug 2022
- FDA classified
- 19 Sep 2022
- Reported
- 21 Sep 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Particulate Matter
- Drug class
- Injectable & IV Drugs
Timeline
| 22 Aug 2022 | Recall initiated by company | |
| 19 Sep 2022 | Classified by FDA | +28 days |
| 21 Sep 2022 | Published in enforcement report | +2 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
Product as listed by the FDA
PROPOFOL Injectable Emulsion, 1 g/100 mL (10 mg/mL), packaged in 100 mL glass fliptop vial (NDC 0409-4699-54) further packaged in a tray of 10 vials (NDC Carton: 0409-4699-24), Rx only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA
Where it was distributed
USA Nationwide
Questions about this recall
Is Propofol Injectable Emulsion (10 mg/mL) recalled?
Yes. Pfizer recalled Propofol Injectable Emulsion (10 mg/mL) on 22 Aug 2022. The recall is Class I and its status is Terminated. Recall number D-1540-2022.
Why was it recalled?
Presence of particulate matter
Which lots are affected?
Lot#: EA7470, Exp 6/1/2023
Where was it sold?
USA 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 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 Propofol recalls
All 17| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Propofol Injectable Emulsion (10 mg/mL) recalled by PfizerPropofol | Pfizer | Particulate Matter | Nationwide |
| Drug | CLASS II | Diprivan (Propofol) Emulsion, 100 mg/mL vial recalledDiprivan | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Diprivan (Propofol) Emulsion, 200 mg per (10mg/mL) vial recalledDiprivan | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS I | Propofol Injectable Emulsion, 1%, 200 mg recalled by HospiraPropofol | Hospira | Packaging Defects | Nationwide |
| Drug | CLASS II | Propofol Injectable Emulsion, 1%, 200 mg/, (10mg/mL) recalled by HospiraPropofol | Hospira | Particulate Matter | Nationwide |