September 2026 FDA Recall Sodium Chloride by Otsuka Icu Medical Llc
99892 - Product Mix-up
This Not Yet Classified drug recall was voluntarily initiated by Otsuka Icu Medical Llc on September 11, 2026 for the product Sodium Chloride. The FDA reported the reason for recall as product mix-up. The product was distributed in Natinowide within the United States and the recall is currently ongoing.
Recall Number:
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
09-11-2026
09-30-2026
258480 bags
Recall Profile & Regulatory Data
Not Yet Classified
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Otsuka ICU Medical LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Natinowide within the United States
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
0.9% Sodium Chloride Injection, 100 mL, USP, ICU Medical, Inc., Lake Forest, Illinois 60045, USA, NDC 0990-7984-23.
Batch or Lot Expiration Information
Lot# : 1042188, Exp. Date 10/31/2027
