ANNOUNCED ONGOING Drug recall · Reported 21 Sep 2026 · FDA company announcement, classification pending
ICU Medical LLC 0.9% Sodium Chloride Injection recalled
Otsuka ICU Medical is recalling ICU Medical LLC 0.9% Sodium Chloride Injection, USP. The recall was initiated on 17 Sep 2026 and is listed as ongoing.
Recall details
- Recall number
- FDA-PR-eec0387fb605
- Recalling firm
- Otsuka ICU Medical
- Brand
- ICU Medical LLC
- Classification
- Pending
- Status
- Ongoing
- Recall initiated
- 17 Sep 2026
- Reported
- 21 Sep 2026
- Reason category
- Packaging Defects
- Drug class
- Injectable & IV Drugs
Timeline
| 17 Sep 2026 | Recall initiated by company | |
| 21 Sep 2026 | Published in enforcement report | +4 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Product mix-up where 0.9% Sodium Chloride Injection, USP overwrap may contain 10 mEq Potassium Chloride Injection. 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
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the company
ICU Medical LLC 0.9% Sodium Chloride Injection, USP, 100 mL
Where it was distributed
Not stated.
Questions about this recall
Why was it recalled?
Product mix-up where 0.9% Sodium Chloride Injection, USP overwrap may contain 10 mEq Potassium Chloride Injection. 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
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does an unclassified recall mean?
The FDA assigns a class once it has assessed the health risk. Until then the recall is listed without one.
Read the official FDA notice · Source record retrieved 26 Sep 2026. This is a company announcement published by the FDA; the FDA has not yet classified the recall. The record is updated when the classification appears in the Enforcement Report. This page reports the record and gives no medical advice.
More recalls from Otsuka ICU Medical
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Potassium Chloride Inj., 20 mEq total in Flexible Container recalledPotassium Chloride | Otsuka ICU Medical | Other | Nationwide |
| Drug | CLASS I | Potassium Chloride Inj., 10 mEq total in Flexible Container recalledPotassium Chloride | Otsuka ICU Medical | Other | Nationwide |
| Drug | CLASS II | 0.9% Sodium Chloride Injection recalled by Otsuka ICU MedicalSodium Chloride | Otsuka ICU Medical | Sterility | Nationwide |