Class I · High risk
PROPOFOL Injectable Emulsion
Presence of particulate matter
Is Propofol recalled?
Not under an active recall.
Propofol was recalled 20 times in the past — all now closed. Most recent: Aug 22, 2022.
Most common reason: Particulate / foreign matter (14 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Propofol. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Propofol recalls on record
none so far in 2026; 20 on record, newest first
Class I · High risk
Propofol Injectable Emulsion
Presence of particulate matter: particulate identified as a beetle.
Class II · Moderate risk
Diprivan (Propofol)
cGMP deviations: Temperature abuse
Class II · Moderate risk
Diprivan (Propofol)
cGMP deviations: Temperature abuse
Class II · Moderate risk
Propofol Injectable Emulsion
cGMP deviations: Temperature abuse
Class II · Moderate risk
Propofol Injectable Emulsion
cGMP deviations: Temperature abuse
Class II · Moderate risk
Propofol1% 10mg/mL injection
Lack of Assurance of Sterility
Class II · Moderate risk
Propofol Injectable Emulsion
Presence of Particulate Matter: The firm received a complaint of an embedded particulate in the neck of one vial composed primarily of iron.
Class I · High risk
Propofol Injectable Emulsion
Temperature Abuse: Products experienced uncontrolled temperature excursions during transit.
Class I · High risk
Propofol Injectable Emulsion
Presence of Particulate Matter: A glass defect was found on the interior neck of the vial during a retain sample inspection where the glass vial contained visible embedded metallic particulate and free floating metallic particulates were also found in solution.
Class II · Moderate risk
Propofol Injectible Emulsion
Presence of Particulate Matter: Glass defect located on the interior neck of the vial identified glass surface abrasions and visible embedded particulate matter which could result in the potential for small glass flakes or embedded metal particulate to become dislodged into the solution.
Class II · Moderate risk
Propofol Injectable Emulsion
Presence of Particulate Matter: Visible particles embedded in the glass identified during a retain sample inspection.
Class II · Moderate risk
Propofol Injectable Emulsion
Presence of Particulate Matter: Visible particulate embedded in the glass vial was observed and confirmed in a sample bottle during retain sample inspection.
Class II · Moderate risk
Propofol Injectable Emulsion
Presence of Particulate Matter; single visible particulate was identified during a retain sample inspection identified as stainless steel
Class II · Moderate risk
Propofol Injectable Emulsion
Presence of Particulate Matter: A single visible particulate was identified during a retain sample inspection.
Class II · Moderate risk
Propofol Injectable Emulsion
Presence of Particulate Matter: Visible particulate embedded in vials was observed and confirmed in a sample bottle during retain inspection.
Class II · Moderate risk
Propofol Injectable Emulsion
Presence of Particulate Matter: Visible particulate and particulate embedded in vials were observed during retain inspection.
Class II · Moderate risk
Propofol Injectable Emulsion
Presence of Particulate Matter: A single visible particulate was observed and confirmed in sample bottles of the recalled lots during retain inspection.
Class II · Moderate risk
Propofol Injectable Emulsion
Presence of Particulate Matter: A single visible particulate was observed and confirmed in a sample bottle during retain inspection.
Class II · Moderate risk
Propofol Injectable Emulsion
Presence of Particulate Matter: A single visible particulate was observed in a retention sample bottles identified as stainless steel
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