Fresenius Kabi 1,000 mL sodium chloride bags recalled over sterility assurance
Fresenius Kabi is recalling one batch of 0.9% Sodium Chloride Injection, USP in 1,000 mL single dose freeflex bags distributed by BD, citing lack of assurance of sterility.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of a sterile injectable where sterility cannot be assured, a risk of harm with no illnesses reported in the source.
Plain-English summary
Fresenius Kabi USA, LLC is recalling 0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL), supplied as 1,000 mL in a single dose freeflex bag and distributed by BD. The unit of sale NDC is 17271-701-07.
The stated reason is lack of assurance of sterility. Sterility is a defining requirement of an injectable product because it is introduced directly into the bloodstream or tissue. The FDA classified the action as Class II.
The affected batch is 24EU10010, expiry 05/31/2027. Distribution was US nationwide, including Alaska and Puerto Rico.
This is a prescription product supplied to healthcare facilities. Facilities should check stock against the batch number above, quarantine affected bags and follow the instructions issued by Fresenius Kabi.
The recalled product
- Product
- SODIUM CHLORIDE (SODIUM CHLORIDE)
- Brand
- SODIUM CHLORIDE
- Manufacturer
- Fresenius Kabi USA, LLC
- Category
- Drug — Injectable solution
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)
- Batch# 24EU10010
- Exp Date: 05/31/2027.
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
- HighSpectra sodium chloride ampules recalled over lack of sterility assurance
FDA (Drugs) · 2026-04-22
- HighFresenius sodium chloride 1,000 mL dialysis-supplied bags recalled over sterility
FDA (Drugs) · 2026-04-15
- HighFresenius Kabi 250 mL sodium chloride injection recalled over sterility assurance
FDA (Drugs) · 2026-04-15
- SevereSodium Chloride Injection Recalled Due to Lack of Assurance of Sterility
FDA (Drugs) · 2026-04-15
- HighFresenius Kabi 50 mL sodium chloride injection 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
- HighXylocaine Injection Recall Due to Hair Contamination
FDA (Drugs) · 2026-07-29
- ModerateGlycopyrrolate Injection Recall Due to Hair Contamination
FDA (Drugs) · 2026-07-29
- ModerateFDA Recalls Xylocaine Injections Due to Hair Contamination
FDA (Drugs) · 2026-07-29
Same hazard · sterility assurance
See all →- HighArrowhead DE LLC Recalls Arrow-LOK Implants Due to Sterility Assurance Concerns
FDA (Devices) · 2026-08-26
- SevereChloraPrep One-Step Applicators Recalled for Potential Packaging Seal Defects
FDA (Drugs) · 2026-07-22
- SeverePemetrexed for Injection Recalled Due to Lack of Sterility Assurance
FDA (Drugs) · 2026-07-15
- SevereChloraPrep One-Step Applicators Recalled Due to Sterility Assurance Failure
FDA (Drugs) · 2026-07-08
- SevereArrow drainage and thoracentesis kits contain recalled supplier drugs
FDA (Devices) · 2026-06-24