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Class II · ModerateActive recall

Sodium Chloride

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberBatch# 23SU10008, Exp Date: 12/31/2026; Batch# 24JU10003, Exp Date: 07/31/2027; Batch# 24LU10011, 24LU10012, Exp Date: 9/30/2027; Batch# 6402273, 6402275, Exp Date: 01/31/2028; Batch# 6402420, 6402421, 6402422, 6402423, Exp Date: 03/31/2028; Batch# 6402473, 6402474, 6402475, 6402476, 6402485, Exp Date: 04/30/2028; Batch# 6402516, Exp Date: 05/31/2028.
Where it was soldUS Nationwide , Alaska, and Puerto Rico.
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Lack of Assurance of Sterility

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byFresenius Kabi USA, LLC
Brand nameSODIUM CHLORIDE
Generic nameSODIUM CHLORIDE
Active ingredient(s)SODIUM CHLORIDE
Distributed by / forFresenius Kabi USA, LLC
NDC65219-470-05
Show the full FDA record
Full product label0.9% 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.
Recalling firmFresenius Kabi USA, LLC
DistributionUS Nationwide , Alaska, and Puerto Rico.
Recall initiated2026-03-11
Report date2026-04-15
Recall completed—
Recall numberD-0427-2026
ClassificationClass II
FDA statusOngoing
Origin on fileLake Zurich IL United States

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Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.