FDA recall, , Moderate risk
Fresenius Kabi Sodium Chloride and Dextrose Injections
Sodium chloride and dextrose injections lack assurance of sterility.
Summary by Recall Canary from the FDA notice
What happened
Fresenius Kabi USA, LLC, of Lake Zurich, Illinois, recalled Sodium Chloride Injection, USP, and Dextrose Injection, USP, products because they lack assurance of sterility. The recall began March 11, 2026, and was added to the FDA's Enforcement Report on April 3, 2026. Distribution was nationwide, including Alaska and Puerto Rico.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Compare the details below with your product and check the FDA notice to confirm whether it is affected.
An NDC (National Drug Code) is usually printed on the drug's label.
Product details
0.9% Sodium Chloride Injection, USP, 50 mL x60, Becton, Dickson and Company, 1 Beckton Drive, Franklin Lakes, NJ 07417 USA, Distributed by BD, Manufactured by Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Sale NDC Number: 17271-701-02.
- Lot code
- 6402428
- 6402481
- 6402482
0.45% Sodium Chloride Injection, USP, 1.125 grams per 250 mL (
- Strength
- 4.5 mg
- NDC
- 63323-626-03
- Lot code
- 6402413
0.9% Sodium Chloride Injection, USP
- Strength
- 900 mg
- NDC
- 65219-432-20
- Lot code
- 23DU10004
- 23HU10006
- NDC
- 65219-282-01
- Lot code
- 23SU10001
- 24AU10003
- 24AU10004
- 24AU10005
- 24AU10008
- 24EU10001
- 24EU10002
- 24PU10002
- 25BU10003
- 25EU10005
- Lot code
- 6402153
- 6402297
- 6402298
- 6402377
- 6402378
- 6402379
- 6402429
- 6402430
- 6402431
- 6402432
- 6402433
- 6402434
- 6402512
- 6402574
- 6402576
- Lot code
- 24EU10010
- Lot code
- 6402290
- 6402291
- 6402411
- 6402412
- 6402419
- 6402424
- 6402425
- 6402426
- 6402427
- 6402479
- 6402480
- 6402517
- 6402571
- 6402518
Some entries omit identifying details. Check the notice to confirm which units are affected.
0.9% Sodium Chloride Injection, USP, 0.9% (
- Strength
- 900 mg
- NDC
- 65219-468-05
- Lot code
- 6402299
- 6402300
- 6402301
- 6402302
- 6402303
- 6402305
- 6402398
- 6402467
- 6402577
- 6402578
0.9% Sodium Chloride Injection, USP, (2
- Strength
- 250 mg
- NDC
- 65219-470-05
- Lot code
- 23SU10008
- 24JU10003
- 24LU10011
- 24LU10012
- 6402273
- 6402275
- 6402420
- 6402421
- 6402422
- 6402423
- 6402473
- 6402474
- 6402475
- 6402476
- 6402485
- 6402516
0.9% Sodium Chloride Injection, USP 0.9% (
- Strength
- 450 mg
- NDC
- 65219-466-05
- Lot code
- 6402372
- 6402374
- 6402437
0.9% Sodium Chloride Injection, USP, (4
- Strength
- 500 mg
- NDC
- 65219-472-05
- Lot code
- 24LU10013
- 24LU10014
- 24NU10001
- 24NU10002
5% Dextrose Injection, USP 5 g per 100 mL (
- Strength
- 50 mg
- NDC
- 65219-464-05
- Lot code
- 6402399
- 6402400
- 6402401
5% Dextrose Injection, USP 12.5 g per 250 mL (
- Strength
- 50 mg
- NDC
- 65219-458-05
- Lot code
- 6402165
5% Dextrose Injection, USP 2.5 g per 50 mL (
- Strength
- 50 mg
- NDC
- 65219-456-05
- Lot code
- 6402296
From the FDA notice
0.9% Sodium Chloride Injection, USP, (2,250 mg per 250 mL) (9 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: 65219-470-05, Unit of Sale NDC Number: 65219-470-30.
Recall details
- Company began the recall
- Sold in
US Nationwide , Alaska, and Puerto Rico.
- Company
- Fresenius Kabi USA, LLCLake Zurich, Illinois
- Hazard
- Sterility problem
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98581
- Recall numbers
- D-0424-2026 to D-0437-2026
All recalls from Fresenius Kabi USA, LLC
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
Summary updated
