Intralipid 20%, A 20% I.V. Fat Emulsion, 100 ml bag, Rx only, Manufactured by Fresenius Kabi, Upp...

FDA Drug Recall #D-0030-2018 — Class I — September 15, 2017

Recall Summary

Recall Number D-0030-2018
Classification Class I — Serious risk
Date Initiated September 15, 2017
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Baxter Healthcare Corporation
Location Deerfield, IL
Product Type Drugs
Quantity 910 bags

Product Description

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.

Distribution Pattern

Impacted shipment sent to Wholesalers, Medical Facilities and Physicians in CA and NV, but could have been further distributed Nationwide in the USA.

Lot / Code Information

Lot #: 10LE9597, Exp 04/01/19

Other Recalls from Baxter Healthcare Corporation

Recall # Classification Product Date
D-0296-2026 Class II Sterile Water for Irrigation, 250 mL, Single-Do... Dec 22, 2025
D-0596-2025 Class II Acetaminophen Injection 1000 mg/100 mL (10 mg/m... Aug 20, 2025
D-0039-2025 Class II Regadenoson Injection, 0.4 mg/5 mL (0.08 mg/mL)... Oct 30, 2024
D-0649-2024 Class I Heparin (Heparin Sodium in 0.9% Sodium Chloride... Aug 1, 2024
D-0587-2024 Class II Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dial... Jun 17, 2024

Frequently Asked Questions

Stop using the medication immediately and contact your pharmacist. A mislabeling recall can range from a minor technical error (wrong font size) to a serious mix-up where one drug is inside another drug's packaging. If you received a medication that looks or acts differently than expected, or if you experienced unexpected effects, tell your doctor immediately. The pharmacist can verify whether your specific lot is affected and provide a replacement. Report any adverse effects experienced to FDA MedWatch at 1-800-FDA-1088.

Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.

Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.

What Should You Do?

Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.