Why it was recalled
Lack of Assurance of Sterility
Product description
0.45% Sodium Chloride Injection, USP, 1.125 grams per 250 mL (4.5 mg per mL), 250 mL in a 250 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC: 63323-626-03, Unit of Sale NDC Number: 63323-626-25 (30 bags in 1 case).
Lot numbers, UPCs & expiration codes
Batch # 6402413, Exp Date: 02/29/2028
Where it was sold
US Nationwide , Alaska, and Puerto Rico.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0424-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Mar 11, 2026
- FDA report date
- Apr 15, 2026
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Fresenius Kabi USA, LLC
Original FDA data
Every field from FDA enforcement report D-0424-2026, exactly as published.
Show all FDA fields
- City
- Lake Zurich
- State
- IL
- Status
- Ongoing
- Country
- United States
- Event ID
- 98581
- Address
- 3 Corporate Dr
- Code information
- Batch # 6402413, Exp Date: 02/29/2028
- Postal code
- 60047-8930
- Report date
- Apr 15, 2026
- Product type
- Drugs
- Recall number
- D-0424-2026
- Classification
- Class II
- Recalling firm
- Fresenius Kabi USA, LLC
- Reason for recall
- Lack of Assurance of Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 0.45% Sodium Chloride Injection, USP, 1.125 grams per 250 mL (4.5 mg per mL), 250 mL in a 250 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC: 63323-626-03, Unit of Sale NDC Number: 63323-626-25 (30 bags in 1 case).
- Distribution pattern
- US Nationwide , Alaska, and Puerto Rico.
- Recall initiation date
- Mar 11, 2026
- Initial firm notification
- Letter
- Center classification date
- Apr 3, 2026