Agency classClass IIOur severity:High FDA (Drugs)·D-0430-2026·Announced 2026-04-15

Fresenius Kabi 100 mL sodium chloride bags for BD recalled over sterility

Fresenius Kabi is recalling 0.9% Sodium Chloride Injection, USP in 100 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 100 mL in a single dose freeflex bag and distributed by BD.

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.

Distribution was US nationwide, including Alaska and Puerto Rico. Affected batch numbers are listed in the recall notice.

This is a prescription product supplied to healthcare facilities. Facilities should check stock against the batch numbers in the recall notice, 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 (20)

Batch# 6402153
Exp Date: 11/30/2026
Batch# 6402297
6402298
Exp Date: 01/31/2027
Batch# 6402377
6402378
6402379
Exp Date: 02/28/2027
Batch # 6402429
6402430
6402431
6402432
6402433
Exp Date: 03/31/2027
Batch# 6402434
Exp Date: 04/30/2027
Batch# 6402512
Exp Date: 05/2027
Batch# 6402574

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 100 mL sodium chloride freeflex bags recalled over sterility
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 →

Severe
Fresenius Kabi Recalls Tyenne Injection Due to Glass Particles
FDA (Drugs) · 2026-09-02
Critical
Fresenius Kabi Recalls Morphine Syringes Due to Labeling Error
FDA (Drugs) · 2026-08-26
High
Naropin Injection Recall Over Particulate Matter Contamination
FDA (Drugs) · 2026-07-29
Moderate
Glycopyrrolate Injection Recall Due to Hair Contamination
FDA (Drugs) · 2026-07-29
High
Xylocaine Injection Recall Due to Hair Contamination
FDA (Drugs) · 2026-07-29

Same hazard · sterility assurance