Fresenius Recalls 0.9% Sodium Chloride Injection Due to Sterility Concerns
Fresenius Medical Care is recalling 25,356 bags of 0.9% Sodium Chloride Injection due to a lack of assurance of sterility.
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 recall is classified as FDA Class II, and the hazard involves a lack of assurance of sterility in an injectable product, which poses a significant risk of serious injury or infection.
Plain-English summary
Fresenius Medical Care Renal Therapies Group, LLC is recalling 25,356 bags of 0.9% Sodium Chloride Injection, USP, 1000 mL. The product is identified by NDC 49230-0300-10, Lot # 17LU05005, and an expiration date of 09/18. The recall was initiated due to a lack of assurance of sterility.
The affected product was distributed throughout the United States. The source text does not specify specific states or facilities where the product was shipped, only that distribution was nationwide.
Healthcare providers and patients should stop using the affected product and contact the manufacturer or their supplier for further instructions. The source text does not provide specific contact information or a return address for the recalled items.
The recalled product
- Product
- 0.9% Sodium Chloride Injection, USP, 1000 mL, Rx Only, Fresenius Medical Care North America, Waltham, MA 02451, NDC 49230-0300-10.
- Category
- Drug — Injectable Solution
- 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 (2)
- Lot # 17LU05005
- Exp. 09/18 Part Number 060-10109
Distribution
Distribution scope not specified by the agency.
Related recalls
Same manufacturer · Fresenius Medical Care Renal Therapies Group, LLC
See all →- ModerateFresenius CombiSet Hemodialysis Blood Tubing Set Recalled for Handling Review
FDA (Devices) · 2026-09-30
- SevereFresenius 5008X HD/HDF Blood Tubing Set Recalled for Leak Risk
FDA (Devices) · 2026-09-09
- ModerateFresenius NaturaLyte Liquid Acid Concentrate Recalled for Discoloration
FDA (Devices) · 2026-09-09
- SevereFresenius 5008X Blood Tubing Set Recalled for Potential Blood Leak
FDA (Devices) · 2026-09-09
- SevereFresenius 5008X HD/HDF Blood Tubing Set Recalled for Leak Risk
FDA (Devices) · 2026-09-09
Same hazard · sterility
See all →- SevereK.C. Pharmaceuticals Recalls Target Eye Drops for Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereFDA Recalls Tri-MIX Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereFDA Recalls Semaglutide/Cyanocobalamin Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereFDA Recalls Tirzepatide Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereK.C. Pharmaceuticals Recalls Leader Advanced Relief Eye Drops for Sterility Concerns
FDA (Drugs) · 2026-10-14
Similar recalls
- ModerateFresenius Recalls Sodium Chloride Injection Bags Due to Sterilization Issue
FDA (Drugs) · 2020-03-25
- 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
- SevereFresenius Sodium Chloride Injection Recall: Lack of Sterility Assurance
FDA (Drugs) · 2025-07-02
- SevereSodium Chloride Injection Recalled Due to Lack of Assurance of Sterility
FDA (Drugs) · 2026-04-15