Reported Sep 30, 2026 · Ongoing · Updated Oct 7, 2026
0.9% Sodium Chloride Injection, 100 mL, USP, ICU Medical, Inc., Lake Forest, Illinois 60045, USA, NDC 0990-7984-23.
Otsuka ICU Medical LLC
Risk not classifiedThe agency has not ranked the risk yet — treat the notice as a caution.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, 100 mL, USP, ICU Medical, Inc., Lake Forest, Illinois 60045, USA, NDC 0990-7984-23.
- Lot codes and dates
Lot #: 1042188Exp. Date 10/31/2027
- Amount recalled
- 258480 bags
Why it was recalled
Product Mix-up: 0.9% SODIUM CHLORIDE Injection, USP may potentially contain the overwrap with labeling indicating it to be 0.9% SODIUM CHLORIDE Injection, USP but the actual product within the overwrap may be POTASSIUM CHLORIDE Inj.10 mEq
The agency has not ranked the risk yet — treat the notice as a caution.
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.