Otsuka ICU Medical LLC Issues Voluntary Nationwide Recall of 0.9% Sodium Chloride Injection, USP Due To a Product Mix-up with 10 mEq Potassium Chloride Injection

FDA recall notice · announced September 17, 2026 · Otsuka Icu Medical

Not Yet Classified

The product

0.9% Sodium Chloride Injection, 100 mL, USP, ICU Medical, Inc., Lake Forest, Illinois 60045, USA, NDC 0990-7984-23.

Reason for recall

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

Notes

Distribution: Natinowide within the United States
Lot/code information: Lot #: 1042188, Exp. Date 10/31/2027
Quantity: 258480 bags
Status: Ongoing
Products in this recall event:
- 0.9% Sodium Chloride Injection, 100 mL, USP, ICU Medical, Inc., Lake Forest, Illinois 60045, USA, NDC 0990-7984-23.

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.