Reported Nov 5, 2025 · Ongoing
0.9% SODIUM CHLORIDE Injection, USP, 100 mL, Rx only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC…
Otsuka ICU Medical LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Otsuka ICU Medical LLC · 3900 Howard Ln · Austin, TX · 78728-6515
Is this the product you have?
- 0.9% SODIUM CHLORIDE Injection, USP, 100 mL, Rx only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 0990-7984-37
- Lot codes and dates
- Lot # 1029921
- Exp Date28 February 2027
- Amount recalled
- 509,360 100 mL bags
Where it was sold
- Nationwide
Why it was recalled
Lack of Assurance of Sterility: Potential for flexible container leaks.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Otsuka ICU Medical LLC recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.