United States
Otsuka ICU Medical LLC is recalling 0.9% Sodium Chloride Injection, USP 100 mL single pack (NDC 0990-7984-23, Lot 1042188, exp. 31 Oct 2027) because the overwrap labeled as 0.9% sodium chloride may contain a 10 mEq Potassium Chloride Injection 100 mL bag (NDC 0990-7074-26) inside. The recall was issued due to a product mix-up that could lead to inadvertent administration of highly concentrated potassium chloride, with potentially serious or fatal outcomes. Customers and distributors should check inventory, quarantine affected product, discontinue use, and follow return instructions from ICU Medical.
What's being recalled
September 17, 2026 AUSTIN, TX – Otsuka ICU Medical LLC is issuing a voluntary recall for one lot of 0.9% SODIUM CHLORIDE Injection, USP, 100mL single pack to the user level due to a potential mix-up. The affected lot of 0.9% SODIUM CHLORIDE Injection, USP (NDC: 0990-7984-23 Lot 1042188) may potentially contain the overwrap with labeling indicating it to be 0.9% SODIUM CHLORIDE Injection, USP (NDC: 0990-7984-23) but the actual product within the overwrap may be POTASSIUM CHLORIDE Inj. 10 mEq, (NDC 0990-7074-26) Lot 1035181. The issue has been identified through a customer complaint where a 10 mEq Highly Concentrated POTASSIUM CHLORIDE Injection 100 mL bag was found inside an overwrap of 0.9% SODIUM CHLORIDE Injection, USP 100 mL.
Risk Statement:
There is a reasonable probability that inadvertent injection of highly concentrated potassium chloride results in adverse events and potentially fatal outcomes. For populations most at risk, which include premature infants, patients on chronic parenteral nutrition, patients who have a history of cardiac arrhythmias, patients with chronic renal insufficiency, patients who have acute renal failure, and patients on potassium-sparing diuretics, there is a reasonable probability of adverse events such as neuromuscular dysfunction including muscle weakness, ascending paralysis, listlessness, vertigo, mental confusion, hypotension, cardiac dysrhythmias, or death from cardiac arrest. To date, Otsuka ICU Medical LLC has not received any reports of adverse events related to this recall.
Affected Product:
Table 1: Affected Product
NDC Number: 0990-7984-23; List Number: 07984-23; Product Description: 0.9% SODIUM CHLORIDE Injection, USP; Lot Number: 1042188; Expiration Date: 31 October 2027; Configuration: 100 mL in flexible container; Label Example: See below
DESCRIPTION OF CASES BEING RECALLED:
NDC Number: 0990-7984-23; Barcode Number GTIN: (01)30309907984231; Lot Number: 1042188; Expiration Date: 31 October 2027; Configuration: 100 mL in flexible container
For further inquiries, please contact ICU Medical using the information provided below.
ICU Medical Contact: Global Complaint Management; Contact Information: 1-(866)-216-8806 or globalcomplaints@icumed.com; Areas of Support: Reporting product complaints
ICU Medical Contact: Drug Safety; Contact Information: 1-844-654-7780 or DrugSafety@icumed.com; Areas of Support: Reporting adverse events for IV Solutions & Drugs
ICU Medical Contact: Medical Information; Contact Information: 1-800-241-4002, option 6 or medinfo_us@icumed.com; Areas of Support: Medical inquiries
ICU Medical Contact: Field Action Processing; Contact Information: marketaction@mailac.custhelp.com; Areas of Support: Questions about this action and response forms
The U.S. Food and Drug Administration (FDA) has been notified of this action.
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
Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Company Contact Information
Consumers:
(844) 654-7780
Media:
Harrison Richards
(949) 366-4261
Harrison.Richards@icumed.com
Product Photos
The hazard
Product mix-up where 0.9% Sodium Chloride Injection, USP overwrap may contain 10 mEq Potassium Chloride Injection
What to do
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.
ICU Medical Contact: Customer Care; Contact Information: 1-(800)-258-5361 or customerservice@icumed.com; Areas of Support: Product credit Return instructions
Contact: Consumers: (844) 654-7780 Media: Harrison Richards (949) 366-4261 Harrison.Richards@icumed.com
Where it was sold
The affected product lot was manufactured on 13 November 2025 and distributed in the United States between 30 December 2025 and 22 June 2026. An image of the overwrap and the mixed-up product is provided below. Please note that the incorrect product being overwrapped with a Sodium Chloride overwrap contains its own label and clearly indicates it to be POTASSIUM CHLORIDE Inj. 10 mEq. The affected product information is provided in Table 1 below:
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration, collected from U.S. Food and Drug Administration. Check the original before you act on it.
Read the official notice (opens in a new tab)