Quick answers
- What is Smoflipid used for?
- The FDA-approved label (Smoflipid, Fresenius Kabi USA, LLC, August 15, 2025) says: “SMOFlipid is indicated in adult and pediatric patients, including term and preterm neonates, as a source of calories and essential fatty acids for parenteral nutrition (PN) when oral or enteral nutrition is not possible, insufficient, or contraindicated. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Smoflipid have a boxed warning?
- No. None of the 1 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Smoflipid?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Smoflipid been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Smoflipid?
- 1 company lists prescription products of Smoflipid in the FDA NDC Directory, including Fresenius Kabi USA, LLC.
What Smoflipid is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
SMOFlipid is indicated in adult and pediatric patients, including term and preterm neonates, as a source of calories and essential fatty acids for parenteral nutrition (PN) when oral or enteral nutrition is not possible, insufficient, or contraindicated. …
— FDA label: Smoflipid, Fresenius Kabi USA, LLC, effective August 15, 2025. Read the full label on DailyMed →
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.
Forms and how it is given
| Dosage forms | Injection, emulsion |
|---|---|
| Route | Intravenous |
| Prescription products | 1 in the FDA NDC Directory |
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, LLC1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA207648 SMOFLIPID 20% | Fresenius Kabi USA | July 13, 2016 | 4, latest July 24, 2025 2025: Labeling · 2023: Labeling · 2022: Efficacy |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| SPL set ID of the quoted label | e0e9d917-ff6f-488e-a6a8-0ad59dd17d80 |
|---|---|
| FDA labels (SPL) | 1 |
| FDA applications | NDA207648 |
| Active ingredients (FDA) | FISH OIL / MEDIUM-CHAIN TRIGLYCERIDES / OLIVE OIL / SOYBEAN OIL |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Smoflipid, Fresenius Kabi USA, LLC, effective August 15, 2025; 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 →