FDA-Drug2026-09-30Not Yet ClassifiedMISBRANDING
ICU Medical sodium chloride injection recalled for potassium chloride product mix-up
What this means
ICU Medical's 0.9% Sodium Chloride Injection (100 mL) may be mislabeled. Some bags marked as sodium chloride may actually contain potassium chloride instead. This mix-up affects lot 1042188, expiring 10/31/2027, distributed nationwide.
- Check the lot number on sodium chloride injection bags: if lot 1042188, do not use.
- Verify the actual product inside matches the label before administering.
- Contact your pharmacy or hospital distributor if you have affected product.
- Report any patient exposure to your healthcare facility's pharmacy or poison control immediately.
The agency's original wording
Hazard
Product Mix-up: 0.9% SODIUM CHLORIDE Injection, USP may potentially contain the overwrap with labeling indicating it to be 0.9% SODIUM CHLORIDE Injection, USP but the actual product within the overwrap may be POTASSIUM CHLORIDE Inj.10 mEq
Intended for
All ages
Illnesses reported
None reported
Sold states
Natinowide within the United States
Affected count
258480 bags
Manufactured in
3900 Howard Ln, Austin, TX, United States
Products
0.9% Sodium Chloride Injection, 100 mL, USP, ICU Medical, Inc., Lake Forest, Illinois 60045, USA, NDC 0990-7984-23.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=99892More ICU Medical recalls
Want us to check the next one for you?
We read every CPSC, FDA, USDA, and NHTSA notice and email you a plain-English Sunday brief covering your household — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.