October 2025 FDA Recall Sodium Chloride by Otsuka Icu Medical Llc
D-0143-2026 - Lack of Assurance of Sterility
This Class II drug recall was voluntarily initiated by Otsuka Icu Medical Llc on October 27, 2025 for the product Sodium Chloride. The FDA reported the reason for recall as lack of assurance of sterility. The product was distributed Nationwide and the recall is currently ongoing.
Recall Number: D-0143-2026
Lack of Assurance of Sterility: Potential for flexible container leaks.
10-27-2025
11-05-2025
509,360 100 mL bags
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
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.
Distributed Nationwide in the USA.
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
0.9% SODIUM CHLORIDE Injection, USP, 100 mL, Rx only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 0990-7984-37
Batch or Lot Expiration Information
Lot# 1029921, Exp Date: 28 February 2027
