Limited official informationFDA Drug Enforcement ReportsRecall date: Apr 15, 2026

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, LL...

Full official product description

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.

Verification delayed

The last verified facts remain visible. Last successful verification: Aug 3, 2026, 7:43 PM UTC. A temporary source failure does not mean the recall changed.

Official information is incomplete

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1Is my item affected?

Compare the complete identifiers. Name similarity alone is not a confirmed match.

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.

Identifiers to compare

  • NDC 65219-470-05
  • NDC 65219-470-30
Affected variants from the official event record
Product or modelCodes and lotsQuantityRecall number
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")...Batch# 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.Not listedD-0427-2026

2What is the risk?

The agency's statement is shown without a site-authored severity score.

Lack of Assurance of Sterility

Agency classification: Class II

3What should I do?

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Consumer action is not available in the associated official record. The site does not infer or generate a replacement.

Verify on the official source

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Official evidence

Official scope

Distribution reported by the agency

US Nationwide , Alaska, and Puerto Rico.

Distribution is context, not a confirmed item match. Compare the model, lot, UPC, NDC, or serial number above.

Material change history

  • : affectedSummary changed in the official record.
  • : affectedSummary changed in the official record.