Agency classClass IIOur severity:High FDA (Drugs)·D-0434-2026·Announced 2026-04-15

Fresenius Kabi 1,000 mL sodium chloride bags recalled over sterility assurance

Fresenius Kabi is recalling one batch of 0.9% Sodium Chloride Injection, USP in 1,000 mL single dose freeflex bags distributed by BD, citing lack of assurance of sterility.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall of a sterile injectable where sterility cannot be assured, a risk of harm with no illnesses reported in the source.

Plain-English summary

Fresenius Kabi USA, LLC is recalling 0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL), supplied as 1,000 mL in a single dose freeflex bag and distributed by BD. The unit of sale NDC is 17271-701-07.

The stated reason is lack of assurance of sterility. Sterility is a defining requirement of an injectable product because it is introduced directly into the bloodstream or tissue. The FDA classified the action as Class II.

The affected batch is 24EU10010, expiry 05/31/2027. Distribution was US nationwide, including Alaska and Puerto Rico.

This is a prescription product supplied to healthcare facilities. Facilities should check stock against the batch number above, quarantine affected bags and follow the instructions issued by Fresenius Kabi.

The recalled product

Product: SODIUM CHLORIDE (SODIUM CHLORIDE)
Brand: SODIUM CHLORIDE
Manufacturer: Fresenius Kabi USA, LLC
Category: Drug — Injectable solution
Hazard: sterility-assurance
injectable
class-ii
prescription-drug

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

Batch# 24EU10010
Exp Date: 05/31/2027.

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Part of a larger recall action

This product is one of 14 recalled by Fresenius Kabi USA, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 14 products in this recall →

Same brand · SODIUM CHLORIDE

Critical
B. Braun Recalls Sodium Chloride Injection Due to Particulate Matter
FDA (Drugs) · 2026-09-16
Critical
Baxter Recalls Sodium Chloride Injection Bags Due to Fiberglass Particulates
FDA (Drugs) · 2026-09-09
High
Spectra sodium chloride ampules recalled over lack of sterility assurance
FDA (Drugs) · 2026-04-22
High
Fresenius Kabi 250 mL saline freeflex bags recalled over sterility assurance
FDA (Drugs) · 2026-04-15
High
Fresenius Kabi half-normal saline 250 mL bags recalled over sterility assurance
FDA (Drugs) · 2026-04-15

Same manufacturer · Fresenius Kabi USA, LLC

See all →

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Naropin Injection Recall Over Particulate Matter Contamination
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Same hazard · sterility assurance