Sodium Chloride Injection Recalled Due to Lack of Assurance of Sterility
Fresenius Kabi USA, LLC is recalling certain batches of 0.9% Sodium Chloride Injection due to concerns regarding sterility assurance.
The agency’s classification
FDA (Drugs): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The product is an intravenous drug and the FDA has classified this as a Class II recall involving a lack of sterility assurance.
Plain-English summary
Fresenius Kabi USA, LLC is recalling 0.9% Sodium Chloride Injection, USP (500 mL in a Single Dose freeflex bag) because there is a lack of assurance of sterility.
This recall affects specific batches distributed nationwide, including Alaska and Puerto Rico. Affected batches include Batch# 23DU10004 (Exp Date: 04/30/2026) and Batch# 23HU10006 (Exp Date: 06/30/2026).
Healthcare providers and distributors should check their inventory for the affected lot numbers and contact Fresenius Kabi USA, LLC for further instructions.
The recalled product
- Product
- SODIUM CHLORIDE (SODIUM CHLORIDE)
- Brand
- SODIUM CHLORIDE
- Manufacturer
- Fresenius Kabi USA, LLC
- Category
- Drug — Injectable
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Batch# 23DU10004
- Exp Date: 04/30/2026
- Batch# 23HU10006
- Exp Date: 06/30/2026.
Distribution
Part of a larger recall action
This product is one of 14 recalled by Fresenius Kabi USA, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 14 products in this recall →Related recalls
Same brand · SODIUM CHLORIDE
- CriticalB. Braun Recalls Sodium Chloride Injection Due to Particulate Matter
FDA (Drugs) · 2026-09-16
- CriticalBaxter Recalls Sodium Chloride Injection Bags Due to Fiberglass Particulates
FDA (Drugs) · 2026-09-09
- HighSpectra sodium chloride ampules recalled over lack of sterility assurance
FDA (Drugs) · 2026-04-22
- HighBD-distributed 50 mL sodium chloride injection recalled over sterility assurance
FDA (Drugs) · 2026-04-15
- HighFresenius Kabi half-normal saline 250 mL bags recalled over sterility assurance
FDA (Drugs) · 2026-04-15
Same manufacturer · Fresenius Kabi USA, LLC
See all →- SevereFresenius Kabi Recalls Tyenne Injection Due to Glass Particles
FDA (Drugs) · 2026-09-02
- CriticalFresenius Kabi Recalls Morphine Syringes Due to Labeling Error
FDA (Drugs) · 2026-08-26
- HighNaropin Injection Recall Over Particulate Matter Contamination
FDA (Drugs) · 2026-07-29
- ModerateGlycopyrrolate Injection Recall Due to Hair Contamination
FDA (Drugs) · 2026-07-29
- HighXylocaine Injection Recall Due to Hair Contamination
FDA (Drugs) · 2026-07-29
Same hazard · sterility issue
See all →- SevereAVID Medical Recalls Haylard Continuous Nerve Block Kits
FDA (Devices) · 2026-09-23
- HighMedline IV TEAM PICC Kits Recalled Due to Potential Non-Sterile Product
FDA (Devices) · 2024-10-30
- HighSurgical convenience kits recalled due to sterile packaging failure
FDA (Devices) · 2023-02-22
- HighPharmacy Innovations Progesterone Injectable Vial Recalled for Sterility Concerns
FDA (Drugs) · 2023-02-01
- HighTeleflex RUSCH Pocket Pac Urinary Catheter Kit Recalled for Sterility Concerns
FDA (Devices) · 2022-11-23
Similar recalls
- SevereFresenius Recalls 0.9% Sodium Chloride Injection Due to Sterility Concerns
FDA (Drugs) · 2018-05-30
- SevereFresenius Sodium Chloride Injection Recall: Lack of Sterility Assurance
FDA (Drugs) · 2025-07-02
- HighInjectable Sodium Chloride Solution Recalled Due to Sterility Concerns and Leakage
FDA (Drugs) · 2022-12-14
- HighSaline Solution Injection Recalled Nationwide Due to Sterility and Leakage
FDA (Drugs) · 2022-10-26
- HighSodium Chloride Injection Recalled Due to Storage Temperature Exposure Risk
FDA (Drugs) · 2023-06-07
- ModerateFresenius Recalls Sodium Chloride Injection Bags Due to Sterilization Issue
FDA (Drugs) · 2020-03-25