0.9% Sodium Chloride Injection, USP, 100 mL recall
Otsuka ICU Medical LLC announced this recall on Sep 17, 2026. FDA has not yet published its classification (Class I, II or III) for it; that usually follows within a few weeks, and this page will then point to the classified recall.
Why it was recalled
Product mix-up where 0.9% Sodium Chloride Injection, USP overwrap may contain 10 mEq Potassium Chloride Injection
Cause type: Labeling / mix-up
Wrong label, wrong strength, mixed-up products, or packaging errors. One of the most dangerous causes - you can end up taking the wrong drug or the wrong dose.
What was recalled
0.9% Sodium Chloride Injection, USP, 100 mL
Compare with the code on your package — the lot numbers are listed in FDA’s notice.
Product details
From the FDA NDC directory, for the product codes in this announcement.
| Product | Strength | Form & route | Labeler |
|---|---|---|---|
| Potassium Chloride NDC 00990-7074 |
10 meq/100mL | Injection, Solution Intravenous |
ICU Medical Inc. |
| Sodium Chloride NDC 00990-7984 |
900 mg/100mL | Injection, Solution Intravenous |
ICU Medical Inc. |
- Company
- Otsuka ICU Medical LLC
- Brand
- ICU Medical LLC
- Company announcement
- Sep 17, 2026
- Posted by FDA
- Sep 21, 2026
Check your lot number. Firm-announced recalls are usually the serious ones. Find the lot number on your package and compare it with the lots listed in FDA’s notice; if it matches, do not use it and speak to your pharmacist or prescriber today. Do not stop a prescribed medication without advice.
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