ICU Medical 0.9% Sodium Chloride Injection
0.9% Sodium Chloride Injection may be mixed up with Potassium Chloride Injection, which can cause adverse events and potentially fatal outcomes.
High risk
There is a reasonable chance that taking it could cause serious health problems or death.
FDA Class I recall · How risk is rated
3 photos
What happened
Otsuka ICU Medical LLC is voluntarily recalling one lot of 0.9% Sodium Chloride Injection, USP, 100 mL, due to a potential mix-up. The product may contain an overwrap labeled as 0.9% Sodium Chloride Injection, but the actual product within the overwrap may be Potassium Chloride Injection, 10 mEq.
The affected lot was manufactured on 13 November 2025 and distributed in the United States between 30 December 2025 and 22 June 2026. The recall was initiated on September 11, 2026, and announced on September 17, 2026. The product is manufactured by ICU Medical, Inc., Lake Forest, Illinois.
Summary by Recall Canary from the FDA notice.
What to do
If a code on your package matches:
- Otsuka ICU Medical LLC is notifying its customers, including distributors, of this recall by letter and is requesting the return of all recalled products.
- All customers, including distributors, should check inventory locations within their institution for the affected product in Table 1, quarantine, and discontinue use.
- Upon receipt of the completed response form, ICU Medical Customer Service will contact customers to coordinate a return label and instructions for product return.
- For further inquiries, please contact ICU Medical using the information provided below. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax. Complete and submit the report Online: www.fda.gov/medwatch/report.htm.
Is yours affected?
Compare every listed detail under your product with its label.
0.9% Sodium Chloride Injection, USP
- NDC
- 0990-7984-23
- Lot code
- 1042188
- Best-by
- 31 October 2027
- List number
- 07984-23
- Configuration
- 100 mL in flexible container
- Label example
- See below
Details
- Company began the recall
- Sold in
Affected Product: The affected product lot was manufactured on 13 November 2025 and distributed in the United States between 30 December 2025 and 22 June 2026.
- Event ID
- 99892
- Company
- Otsuka ICU Medical LLC
- Hazard
- Labeling error
- Quantity recalled
- 258,480 container
Company began the recall
Announced by the company
Listed on Recall Canary
Added to FDA's Enforcement Report
In FDA's weekly enforcement report
Classified by FDA
Summary updated
