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.
What this means for you
Illness, injury, or structural failure has been reported. 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.
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