High FDA (Drugs)·D-0433-2026·Announced 2026-04-15

Fresenius sodium chloride 1,000 mL dialysis-supplied bags recalled over sterility

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

What this means for you

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 in cases of ten and distributed by Fresenius Medical Care RTG, LLC. The unit of use NDC is 65219-282-01.

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.

Affected batches are 23SU10001 (exp 12/31/2026); 24AU10003, 24AU10004, 24AU10005 and 24AU10008 (exp 01/31/2027); 24EU10001 and 24EU10002 (exp 05/31/2027); 24PU10002 (exp 11/30/2027); 25BU10003 (exp 02/29/2028); and 25EU10005 (exp 05/31/2028). 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 numbers 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 (16)

Batch# 23SU10001
Exp Date: 12/31/2026
Batch# 24AU10003
24AU10004
24AU10005
24AU10008
Exp Date: 01/31/2027
Batch # 24EU10001
24EU10002
Exp Date: 05/31/2027
Batch# 24PU10002
Exp Date: 11/30/2027
Batch# 25BU10003
Exp Date: 02/29/2028
Batch# 25EU10005
Exp Date: 05/31/2028.

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

High
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FDA (Drugs) · 2026-04-22
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Fresenius Kabi 100 mL sodium chloride bags for BD recalled over sterility
FDA (Drugs) · 2026-04-15
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Fresenius Kabi 100 mL sodium chloride freeflex bags recalled over sterility
FDA (Drugs) · 2026-04-15
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Fresenius Kabi 250 mL saline freeflex bags recalled over sterility assurance
FDA (Drugs) · 2026-04-15
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Fresenius Kabi 250 mL sodium chloride injection recalled over sterility assurance
FDA (Drugs) · 2026-04-15

Same manufacturer · Fresenius Kabi USA, LLC

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Same hazard · sterility assurance