Baxter Intralipid 20% IV Fat Emulsion Recall: Temperature Abuse Risk
Baxter Healthcare recalls Intralipid 20% IV fat emulsion (100ml) due to potential exposure to subfreezing temperatures during transit, which may affect product safety.
Lower-risk recall
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.
Contact the company
What happened, in plain English
Baxter Healthcare is recalling Intralipid 20% IV fat emulsion (100ml bags) because some units were exposed to subfreezing temperatures during shipping. This could cause the product to become unsafe for medical use, especially in critical care settings. Read more at govinfonow.com/recall/41249-baxter-intralipid-20-iv-fat-emulsion-recall-temperature-abuse-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/41249-baxter-intralipid-20-iv-fat-emulsion-recall-temperature-abuse-risk · Updated October 7, 2026 · FDA enforcement record: FDA #D-0030-2018
Cite this page
“Baxter Intralipid 20% IV Fat Emulsion Recall: Temperature Abuse Risk.” GovInfoNow, updated October 7, 2026. https://govinfonow.com/recall/41249-baxter-intralipid-20-iv-fat-emulsion-recall-temperature-abuse-risk. Based on FDA recall #D-0030-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0030-2018%22&limit=1).
Why it’s dangerous
The product was exposed to subfreezing temperatures during transit, which is outside the acceptable storage range. This could potentially alter the product's stability and safety for medical use, though the exact risk level is not specified in the recall.
Who’s affected
Healthcare providers and patients using Intralipid 20% IV fat emulsion for medical treatment. Those most at risk are patients receiving this medication in critical care settings.
How to tell if you have this one
Check for the lot number 10LE9597 on the Intralipid 20% IV fat emulsion (100ml) bag. The product was manufactured by Fresenius Kabi in Uppsala, Sweden and distributed by Baxter Healthcare.
- Brand
Baxter Healthcare- Category
Drug
What to do — step by step
Check Product Lot Number
Look for the lot number 10LE9597 on the Intralipid 20% IV fat emulsion (100ml) bag.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 2 states.
FDA distribution: “Impacted shipment sent to Wholesalers, Medical Facilities and Physicians in CA and NV, but could have been further distributed Nationwide in the USA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Nevada.
Recall timeline
FDA terminated this recall 12 months after the firm started it.
- Firm started the recall
- FDA classified it Class I
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Similar recalls
Other Baxter Healthcare recalls
Latest drug recalls
Keep exploring
Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0030-2018 (September 15, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0030-2018 to see it in context.
- Plain-language summary written by qwen3:4b on October 7, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.