Quick Facts at a Glance
- Recall Date
- March 11, 2026
- Hazard Level
- HIGH
- Brands
- SODIUM CHLORIDE, Fresenius Kabi USA, LLC
- Category
- Health & Personal Care
- Sold At
- Unknown
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL, PREGNANT, ELDERLY
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- SODIUM CHLORIDE, Fresenius Kabi USA, LLC
- Product type
- Intravenous saline injection
- Model numbers
- Batch# 23SU10001, Exp Date: 12/31/2026, Batch# 24AU10003, 24AU10004, 24AU10005, 24AU10008, Exp Date: 01/31/2027, Batch # 24EU10001 +8 more
- UPC codes
- 65219-282, 65219-282-01, 65219-282-10
- Sold at
- Unknown
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
March 11, 2026
Reported by FDA DRUG
April 15, 2026
RecallRadar source check
April 22, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Lack of Assurance of Sterility
What You Should Do
Consumers and healthcare providers should stop using this product immediately. Contact Fresenius Kabi USA, LLC or your healthcare provider for guidance. Notification method: Letter
About This Product
Intravenous saline solutions are used to hydrate patients and deliver medications. This recall involves 0.9% Sodium Chloride Injection in single-dose FreeFlex bags distributed nationwide.
Why This Is Dangerous
Lack of sterility assurance means potential contamination. If contaminated, IV administration can lead to serious infections.
Industry Context
This recall is not part of a broader safety pattern described in the data.
Real-World Impact
Hospitals and clinics may need to quarantine affected batches and switch to alternatives, potentially delaying treatments and increasing costs.
Practical Guidance
How to identify if yours is affected
- Check NDC: 65219-282-01 (Unit of Use) or 65219-282-10 (Unit of Sale)
- Review batch numbers and expiration dates listed in the recall notice (e.g., 23SU10001; 24AU10003-24AU10008; 24EU10001-24EU10002; 24PU10002; 25BU10003; 25EU10005)
- Inspect packaging for FreeFlex 1,000 mL bags
Where to find product info
Recall page: FDA enforcement and manufacturer notification letters
What timeline to expect
Refunds or replacements will be coordinated by healthcare providers or pharmacy networks; timelines vary by batch
If the manufacturer is unresponsive
- Escalate to hospital purchasing department
- Contact FDA recall information line
- Document all communications and batch details
How to prevent similar issues
- Verify sterility and batch traceability for IV solutions before use
- Prefer suppliers with recent sterility testing
- Maintain separation of recalled lots from usable inventory
- Review hospital recall SOPs for IV solutions
Documentation advice
Keep recall letters, batch numbers, expiration dates, and communications with supplier; log any adverse events with the facility risk manager
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Product Details
Brand: Fresenius Kabi USA, LLC. Product: 0.9% Sodium Chloride Injection, USP. Packaging: 1,000 mL FreeFlex bag, single dose, 1,000 mL x 10. NDC: 65219-282-01 (Unit of Use); 65219-282-10 (Unit of Sale). Manufactured by: Fresenius Kabi. Distributed by: Fresenius Medical Care RTG, LLC. Batch numbers and expirations listed in recall notes include: 23SU10001 (Exp 12/31/2026); 24AU10003, 24AU10004, 24AU10005, 24AU10008 (Exp 01/31/2027); 24EU10001, 24EU10002 (Exp 05/31/2027); 24PU10002 (Exp 11/30/2027); 25BU10003, 25EU10005 (Exp 02/29/2028 and 05/31/2028 respectively). Distribution: US Nationwide, AK
Reported Incidents
No injuries or incidents have been reported in the recall notice.
Key Facts
- 72-hour sterility confirmation window implied by recall tone
- Batch numbers with multiple expirations across 2026-2028
- Nationwide distribution including territories (AK, PR)
- Unit of Use NDC 65219-282-01; Unit of Sale NDC 65219-282-10
- Class II recall; high hazard level
Browse More Recalls
Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
Read: What to Do When You Find a Recalled ProductGet Alerts for Health & Personal Care Recalls
Get instant alerts for recalls that affect you. Free forever.