Intralipid 20% — Class I drug recall D-0030-2018
Terminated recall by Baxter Healthcare Corporation, reported 2017-11-01, distributed nationwide. Temperature Abuse: A portion of this product lot was exposed to subfreezing temperatures, which is outside of
| Recall number | D-0030-2018 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corporation, Deerfield, IL, United States |
| Recall initiated | 2017-09-15 |
| Classified | 2017-10-24 |
| Reported by FDA | 2017-11-01 |
| Terminated | 2018-09-06 |
| Distributed | Nationwide (US) |
| Quantity | 910 bags |
| Reason classes | labeling, temperature control |
| NDC | 00338-0519, 00338-0519-09, 00338-0519-13, 00338-0519-58 |
| Lot numbers | 10LE9597 |
| Expiration dates | 2019-04-01 |
Product
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
Reason for 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0030-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.