Quick answers
- What is I.v. fat emulsion used for?
- The FDA-approved label (Intralipid, ProPharma Distribution, January 19, 2026) says: “Intralipid ® is indicated as a source of calories and essential fatty acids for adult and pediatric patients requiring parenteral nutrition (PN) and as a source of essential fatty acids for prevention of essential fatty acid deficiency (EFAD). …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does I.v. fat emulsion have a boxed warning?
- The label we quote has no boxed warning, but 5 of 11 FDA labels for this medicine do. Check the label of your own product.
- Is there a shortage of I.v. fat emulsion?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has I.v. fat emulsion been recalled?
- FDA enforcement reports list 3 recalls of products of this medicine; the newest started April 13, 2022 (Class II). A recall usually concerns specific lots, not every product.
- Who makes I.v. fat emulsion?
- 5 companies list prescription products of I.v. fat emulsion in the FDA NDC Directory, including Fresenius Kabi USA, LLC, Baxter Healthcare Corporation and ProPharma Distribution.
What I.v. fat emulsion is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Intralipid ® is indicated as a source of calories and essential fatty acids for adult and pediatric patients requiring parenteral nutrition (PN) and as a source of essential fatty acids for prevention of essential fatty acid deficiency (EFAD). …
— FDA label: Intralipid, ProPharma Distribution, effective January 19, 2026. Read the full label on DailyMed →
The FDA has 11 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.
5 of 11 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Emulsion · Injection, solution |
|---|---|
| Route | Intravenous |
| Prescription products | 11 in the FDA NDC Directory |
| Brand names | Intralipid, Nutrilipid I.V. Fat Emulsion |
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.
- Fresenius Kabi USA, LLC5 products
- Baxter Healthcare Corporation4 products
- ProPharma Distribution2 products
- Baxter Healthcare Corp1 product
- B. Braun Medical Inc.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA017643 INTRALIPID 10% | Fresenius | October 7, 1975 | 62, latest July 24, 2025 2025: Labeling · 2023: Labeling · 2022: Labeling |
| NDA018449 INTRALIPID 20% | Fresenius | January 23, 1981 | 36, latest July 24, 2025 2025: Labeling · 2023: Labeling · 2023: Labeling |
| NDA019531 NUTRILIPID 10%, NUTRILIPID 20% | B Braun | May 28, 1993 | 7, latest July 24, 2025 2025: Labeling · 2025: Labeling · 2023: Manufacturing (CMC) |
| NDA019942 INTRALIPID 30% | Fresenius | December 30, 1993 | 12, latest July 24, 2025 2025: Labeling · 2024: Labeling · 2023: Labeling |
| NDA020248 INTRALIPID 20% | Fresenius | August 7, 1996 | 14, latest July 24, 2025 2025: Labeling · 2023: Labeling · 2023: Labeling |
Shortage status
The FDA drug shortage list does not show these products.
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.
-
April 13, 2022 · Class II · Terminated · D-1119-2022
cGMP deviations: Temperature abuse
Intralipid (I.V. Fat emulsion), 20%, 250 mL bag, Rx only, MFG: Baxter Healthcare, NDC 0338-0519-09 — Mckesson Medical-Surgical Inc. Corporate Office
-
April 13, 2022 · Class II · Terminated · D-1120-2022
cGMP deviations: Temperature abuse
Intralipid (I.V. Fat emulsion), 20%, 100 mL bag, Rx only, MFG: Baxter Healthcare, NDC 0338-0519-58 — Mckesson Medical-Surgical Inc. Corporate Office
-
September 15, 2017 · Class I · Terminated · D-0030-2018
Temperature Abuse: A portion of this product lot was exposed to subfreezing temperatures, which is outside of the acceptable storage range listed on the product labeling, during transit to a distribution facility.
Intralipid 20%, A 20% I.V. Fat Emulsion, 100 ml bag, Rx only, Manufactured by Fresenius Kabi, Uppsala, Sweden for Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-0519-58 — Baxter Healthcare Corporation
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
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Intralipid, ProPharma Distribution, effective January 19, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- 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 →