Medical emergency?Emergency? Call 911. Nearest emergency roomsNearest ERs

Español Near me My list Help
US Patient GuideUSA
Surprise me
Prescription medicine · generic available

Propofol

Brand names: Diprivan

Drug class: General Anesthetic

The FDA’s “Established Pharmacologic Class”: the group of medicines that work in a similar way.

Full FDA label All drugs

Official FDA data, not advice

Everything here comes from the U.S. Food and Drug Administration (FDA): the drug label, the NDC Directory, Drugs@FDA, recall reports and the drug shortage list. Each fact shows its source and date.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

In an emergency, call 911. If someone may have taken too much of a medicine, call Poison Help: 1‑800‑222‑1222.

At a glance

NoBoxed warning
None listedFDA shortage list
17Recalls (FDA reports)
14Companies
1989First FDA approval on file

Quick answers

What is Propofol used for?
The FDA-approved label (Diprivan, Fresenius Kabi USA, LLC, September 11, 2025) says: “DIPRIVAN is an intravenous general anesthetic and sedation drug indicated for: • Induction of General Anesthesia for Patients Greater than or Equal to 3 Years of Age • Maintenance of General Anesthesia for Patients Greater than or Equal to 2 Months of Age • Initiation and Maintenance of Monitored Anesthesia Care (MAC) Sedation in Adult Patients • Sedation for Adult Patients in Combination with Regional Anesthesia • …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Does Propofol have a boxed warning?
No. None of the 16 FDA labels we found for this medicine has a boxed warning.
Is there a shortage of Propofol?
No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
Has Propofol been recalled?
FDA enforcement reports list 17 recalls of products of this medicine; the newest started August 22, 2022 (Class I). A recall usually concerns specific lots, not every product.
Who makes Propofol?
14 companies list prescription products of Propofol in the FDA NDC Directory, including Fresenius Kabi USA, LLC, Hospira, Inc. and Civica, Inc..

What Propofol is used for

Quoted from the “Indications and Usage” section of the FDA-approved label.

DIPRIVAN is an intravenous general anesthetic and sedation drug indicated for: • Induction of General Anesthesia for Patients Greater than or Equal to 3 Years of Age • Maintenance of General Anesthesia for Patients Greater than or Equal to 2 Months of Age • Initiation and Maintenance of Monitored Anesthesia Care (MAC) Sedation in Adult Patients • Sedation for Adult Patients in Combination with Regional Anesthesia • …

— FDA label: Diprivan, Fresenius Kabi USA, LLC, effective September 11, 2025. Read the full label on DailyMed →

The FDA has 16 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

Boxed warning

A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.

The label quoted above has no boxed warning.

0 of 16 FDA labels for this medicine have a boxed warning.

Forms and how it is given

Dosage formsInjection, emulsion
RouteIntravenous
Prescription products35 in the FDA NDC Directory
Brand namesDiprivan

What pharmacies pay (NADAC)

The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.

This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.

NADAC per unit for Propofol, by strength and form
Strength and formGeneric or brandPharmacies pay
propofol 10 mg/mL
injection, emulsion		 Generic $0.1709 per mL

NADAC list of November 4, 2026; these prices took effect on September 2, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.

Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →

Companies that list this medicine

Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.

FDA approval history

  • NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
  • ANDA: Abbreviated New Drug Application: how a generic version is approved.
Brand and biologic applications
ApplicationSponsorApprovedLater changes approved
NDA019627
DIPRIVAN		 Fresenius Kabi USAOctober 2, 1989 38, latest November 21, 2025
2025: Manufacturing (CMC) · 2022: Labeling · 2021: Labeling

Generic approvals (9)

Shortage status

The FDA drug shortage list does not show these products.

FDA Drug Shortages database →

Recalls

From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.

  1. August 22, 2022 · Class I · Terminated · D-1540-2022

    Presence of particulate matter

    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 — Pfizer Inc.

  2. July 13, 2022 · Class I · Terminated · D-1301-2022

    Presence of particulate matter: particulate identified as a beetle.

    Propofol Injectable Emulsion, 1 g/100 mL (10 mg/mL), packaged in 100 mL per 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., — Pfizer Inc.

  3. April 13, 2022 · Class II · Terminated · D-1116-2022

    cGMP deviations: Temperature abuse

    Diprivan (Propofol) Emulsion, 200 mg per 20 mL (10mg/mL), 20 mL vial, Rx only, MFG: App Pharmaceutical LLC, NDC 63323-269-29 — Mckesson Medical-Surgical Inc. Corporate Office

  4. April 13, 2022 · Class II · Terminated · D-1115-2022

    cGMP deviations: Temperature abuse

    Diprivan (Propofol) Emulsion, 100 mg/mL, 10mL vial, Rx only, MFG: App Pharmaceutical LLC, NDC 63323-269-10 — Mckesson Medical-Surgical Inc. Corporate Office

  5. December 23, 2014 · Class II · Terminated · D-0381-2015

    Presence of Particulate Matter: The firm received a complaint of an embedded particulate in the neck of one vial composed primarily of iron.

    Propofol Injectable Emulsion, 1%, 200 mg/20 mL, (10mg/mL), 20 mL, Single patient infusion vial, Contains Benzyl Alcohol, For I.V. Administration, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-30 — Hospira Inc.

  6. October 6, 2014 · Class I · Terminated · D-0389-2015

    Temperature Abuse: Products experienced uncontrolled temperature excursions during transit.

    Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), 20 mL Single patient infusion vials, packaged in 5 Units per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-30. — Hospira Inc.

  7. April 2, 2014 · Class I · Terminated · D-1547-2014

    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.

    Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), For I.V. Administration, Rx Only, 20 mL vial, Contains Benzyl Alcohol, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-4699-30 — Hospira Inc.

  8. December 12, 2013 · Class II · Terminated · D-1033-2014

    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.

    Propofol Injectible Emulsion, 1%, 200 mg/20 mL (10 mg/mL), 20 mL Single patient infusion vial, packaged in 5 Units x 20 mL per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-30. — Hospira Inc.

  9. October 11, 2013 · Class II · Terminated · D-66637-001

    Presence of Particulate Matter: Visible particles embedded in the glass identified during a retain sample inspection.

    Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), 20 mL single patient infusion vial packaged in 5 Units x 20 mL per carton, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-30. — Hospira Inc.

  10. August 14, 2013 · Class II · Terminated · D-932-2013

    Presence of Particulate Matter: Visible particulate embedded in the glass vial was observed and confirmed in a sample bottle during retain sample inspection.

    Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), packaged in 5 Units x 20 mL Single patient infusion vials per carton, Rx only, Hospira, Inc. Lake Forest, IL 60045, NDC 0409-4699-30 — Hospira Inc.

  11. May 25, 2013 · Class II · Terminated · D-887-2013

    Presence of Particulate Matter; single visible particulate was identified during a retain sample inspection identified as stainless steel

    Propofol Injectable Emulsion, 1%, 1 g/100 mL (10 mg/mL), 100 mL, Single patient infusion vial, RX only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-24; Propofol Injectable Emulsion, 500 mg/50 mL, 50 mL, Single pa — Hospira Inc.

  12. April 8, 2013 · Class II · Terminated · D-297-2013

    Presence of Particulate Matter: A single visible particulate was identified during a retain sample inspection.

    Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), 20 mL Single patient infusion vial, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-30. — Hospira Inc.

  13. February 25, 2013 · Class II · Terminated · D-223-2013

    Presence of Particulate Matter: Visible particulate embedded in vials was observed and confirmed in a sample bottle during retain inspection.

    Propofol Injectable Emulsion, 1%, packaged in a) 5 x 20 mL Single patient infusion vials per carton, 200 mg/20 mL (10 mg/mL), NDC 0409-4699-30; b) 10 x 100 mL Single patient infusion vials per carton, 1 g/100 mL (10 mg/m — Hospira Inc.

  14. November 15, 2012 · Class II · Terminated · D-159-2013

    Presence of Particulate Matter: Visible particulate and particulate embedded in vials were observed during retain inspection.

    Propofol Injectable Emulsion, 1%, packaged in a) 20 mL Single patient infusion vial, 200 mg/20 mL (10 mg/mL), NDC 0409-4699-30; b) 50 mL Single patient infusion vial, 500 mg/50 mL (10 mg/mL), NDC 0409-4699-33; c) 100 mL — Hospira Inc.

  15. August 29, 2012 · Class II · Terminated · D-1685-2012

    Presence of Particulate Matter: A single visible particulate was observed and confirmed in sample bottles of the recalled lots during retain inspection.

    Propofol Injectable Emulsion, 1%, packaged in a) 20 mL Single patient infusion vial, 200 mg/20 mL (10 mg/mL), NDC 0409-4699-30; b) 50 mL Single patient infusion vial, 500 mg/50 mL (10 mg/mL), NDC 0409-4699-33; c) 100 mL — Hospira Inc.

  16. August 3, 2012 · Class II · Terminated · D-1672-2012

    Presence of Particulate Matter: A single visible particulate was observed and confirmed in a sample bottle during retain inspection.

    Propofol Injectable Emulsion, 1%, 1 g/100 mL (10 mg/mL), 100 ml Single patient infusion vial, Rx only, Hospira, Inc. Lake Forest, IL 60045 USA, NDC 0409-4699-24 — Hospira Inc.

  17. April 11, 2012 · Class II · Terminated · D-1382-2012

    Presence of Particulate Matter: A single visible particulate was observed in a retention sample bottles identified as stainless steel

    Propofol Injectable Emulsion, 1%, (10mg/mL), packaged in a) 200 mg/20 mL, 5 Units x 20 mL Single patient infusion vials per carton (NDC 0409-4699-30); b) 1 g/100 mL, 10 Units x 100 mL Single patient infusion vials per ca — Hospira, Inc.

What do the recall classes mean?

Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).

Official identifiers

RxCUI (RxNorm)1808217, 1808219, 1808222, 1808223, 1808224, 1808225, 1808234, 1808235
SPL set ID of the quoted labele3105799-a4b6-f3f4-e6e2-b2b29bbdb538
FDA labels (SPL)16
FDA applicationsNDA019627, 9 ANDA
Active ingredients (FDA)PROPOFOL

Sources

  1. FDA-approved label on DailyMed (National Library of Medicine) — Diprivan, Fresenius Kabi USA, LLC, effective September 11, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
  2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
  5. Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026

openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →

Report an error → · Information for medicine makers