0.9% Sodium Chloride 100 mL bags recalled due to potential KCl mix-up
Otsuka ICU Medical LLC voluntarily recalled lots of 0.9% Sodium Chloride Injection USP 100 mL because the overwrap may contain a 10 mEq Potassium Chloride Injection bag. An inadvertent KCl infusion carries risk of cardiac arrhythmia and death. Healthcare facilities are asked to quarantine all affected lots immediately.
On 21 September 2026 Otsuka ICU Medical LLC voluntarily recalled specific lots of 0.9% Sodium Chloride Injection USP 100 mL because the outer overwrap may contain a bag of 10 mEq Potassium Chloride (KCl) Injection. The FDA recall notice ↗ includes affected lot numbers.
Why a KCl mix-up is life-threatening
Undiluted or concentrated potassium chloride administered intravenously can cause rapid and fatal cardiac arrhythmia, including ventricular fibrillation and asystole. KCl is a high-alert medication ↗ (Institute for Safe Medication Practices) — meaning mistakes with it are disproportionately likely to cause severe patient harm. Concentrated KCl should never be stocked undiluted in clinical care areas; this recall highlights packaging-line segregation failure.
What hospitals and pharmacies should do
All affected lots must be immediately quarantined and removed from patient-care areas. Before administering any 0.9% NaCl 100 mL bag from inventory: visually inspect the overwrap and inner bag labelling. Contact Otsuka ICU Medical for return instructions. Report any adverse events or close calls to FDA MedWatch ↗ and to ISMP ↗.
FAQ
How do I know if my batch is affected by this recall?
Check the lot number printed on the product label or carton against the specific lots listed in the official FDA recall notice ↗. If your lot number matches, do not use the product and contact your pharmacy or the recalling firm. You can also search the FDA Recalls database ↗ for the latest status.
What recall class is this?
FDA assigns recall classes: Class I (most serious — reasonable probability of serious adverse health consequences or death), Class II (may cause temporary or medically reversible adverse health consequences), or Class III (unlikely to cause adverse health consequences). The class is listed in the official notice ↗. For definitions see the FDA recall classification guide ↗.