thejoe Sodium Chloride

Sodium Chloride recalls: 73 FDA reports

Recalls involving Sodium Chloride. What was wrong with each batch, and how the FDA graded the risk.

73Reports

14Class I

22Ongoing

2026-04-22Most recent

14 Class I on this page

Class I means the FDA judged there was a reasonable probability of serious harm or death. Check the lot numbers against anything you hold.

What the classes mean

The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.

Class	What the FDA is saying
Class I	There is a reasonable probability that using this will cause serious harm or death.
Class II	It may cause temporary or reversible harm. Serious harm is unlikely.
Class III	It breaks a rule but is unlikely to hurt anyone. Often a labelling fault.

Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.

By class

Class	Reports
Class II	57
Class I	14
Class III	2

By year reported

Year	Reports
2013	5
2014	8
2015	9
2016	4
2017	2
2018	5
2019	7
2020	2
2021	1
2022	5
2023	6
2024	1
2025	6
2026	12

Checking whether it affects you

The lot or code number is what matters. Not the product name. A recall covers specific lots. Yours may not be one of them.

Check the code on your package against the report. The FDA keeps the current list at fda.gov/safety/recalls.

The reports

The text below is quoted from the FDA record word for word.

0.9% Sodium Chloride Injection, USP, 10 mL Ampules, Rx only, Single Dose, Preservative Free, Manufactured for:

D-0531-2026 · Class II · reported 2026-04-22 · Ongoing

Why it was recalled: Lack of Assurance of Sterility
Product: 0.9% Sodium Chloride Injection, USP, 10 mL Ampules, Rx only, Single Dose, Preservative Free, Manufactured for: Spectra Medical Devices, LLC, Wilmington, MA, 01887, By: Houns Co., Ltd, Jecheon, Korea, 27159, NDC 65282-1510-1.
Where it went: USA Nationwide.
How much: 7,120,750 ampules

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 o

D-0427-2026 · Class II · reported 2026-04-15 · Ongoing

Why it was recalled: Lack of Assurance of Sterility
Product: 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.
Where it went: US Nationwide , Alaska, and Puerto Rico.

0.45% Sodium Chloride Injection, USP, 1.125 grams per 250 mL (4.5 mg per mL), 250 mL in a 250 mL freeflex bag,

D-0424-2026 · Class II · reported 2026-04-15 · Ongoing

Why it was recalled: Lack of Assurance of Sterility
Product: 0.45% Sodium Chloride Injection, USP, 1.125 grams per 250 mL (4.5 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: 63323-626-03, Unit of Sale NDC Number: 63323-626-25 (30 bags in 1 case).
Where it went: US Nationwide , Alaska, and Puerto Rico.

0.9% Sodium Chloride Injection, USP 900 mg per 100 mL (9 mg per mL) 500 mL in a Single Dose freeflex bag, 500

D-0432-2026 · Class II · reported 2026-04-15 · Ongoing

Why it was recalled: Lack of Assurance of Sterility
Product: 0.9% Sodium Chloride Injection, USP 900 mg per 100 mL (9 mg per mL) 500 mL in a Single Dose freeflex bag, 500 mL x 20, Manufactured for: Fresenius Kabi USA, LLC ("Fresenius Kabi"), IL 60047, Unit of Use NDC: 65219-432-20, Unit of Sale NDC Number: 65219-432-85.
Where it went: US Nationwide , Alaska, and Puerto Rico.

0.9% Sodium Chloride Injection, USP, 0.9% (900 mg per 100 mL) (9 mg per mL) 100 mL in a 100 mL freeflex bag, R

D-0426-2026 · Class II · reported 2026-04-15 · Ongoing

Why it was recalled: Lack of Assurance of Sterility
Product: 0.9% Sodium Chloride Injection, USP, 0.9% (900 mg per 100 mL) (9 mg per mL) 100 mL in a 100 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 600047, Unit of Use NDC: 65219-468-05, Unit of Sale NDC Number: 65219-468-50.
Where it went: US Nationwide , Alaska, and Puerto Rico.

0.9% Sodium Chloride Injection, USP, (4,500 mg per 500 mL) (9 mg per mL) 500 mL in a 500 mL freeflex bag, Rx o

D-0428-2026 · Class II · reported 2026-04-15 · Ongoing

Why it was recalled: Lack of Assurance of Sterility
Product: 0.9% Sodium Chloride Injection, USP, (4,500 mg per 500 mL) (9 mg per mL) 500 mL in a 500 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC: 65219-472-05, Unit of Sale NDC Number: 65219-472-20.
Where it went: US Nationwide , Alaska, and Puerto Rico.

0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 100 mL in a Single Dose freeflex bag, Rx

D-0430-2026 · Class II · reported 2026-04-15 · Ongoing

Why it was recalled: Lack of Assurance of Sterility
Product: 0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 100 mL in a Single Dose freeflex bag, Rx only, BD Beckton, Dickson and Company, 1 Beckton Drive, Franklin Lakes, NJ 07417 USA, Distributed by BD, Manufactured by: Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Sale NDC Number: 17271-701-03.
Where it went: US Nationwide , Alaska, and Puerto Rico.

0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 1,000 mL in a Single Dose freeflex bag, 1

D-0433-2026 · Class II · reported 2026-04-15 · Ongoing

Why it was recalled: Lack of Assurance of Sterility
Product: 0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 1,000 mL in a Single Dose freeflex bag, 1,000 mLx10, Fresenius Medical Care, Waltham, MA 02451, Distributed by: Fresenius Medical Care RTG, LLC, Manufactured by: Fresenius Kabi, Unit of Use NDC: 65219-282-01, Unit of Sale NDC Number: 65219-282-10.
Where it went: US Nationwide , Alaska, and Puerto Rico.

0.9% Sodium Chloride Injection, USP 0.9% (450 mg per 50 mL) (9 mg per mL) 50 mL, Rx only, Fresenius Kabi USA,

D-0425-2026 · Class II · reported 2026-04-15 · Ongoing

Why it was recalled: Lack of Assurance of Sterility
Product: 0.9% Sodium Chloride Injection, USP 0.9% (450 mg per 50 mL) (9 mg per mL) 50 mL, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC: 65219-466-05, Unit of Sale NDC Number: 65219-466-60.
Where it went: US Nationwide , Alaska, and Puerto Rico.

0.9% Sodium Chloride Injection, USP, 50 mL x60, Becton, Dickson and Company, 1 Beckton Drive, Franklin Lakes,

D-0429-2026 · Class II · reported 2026-04-15 · Ongoing

Why it was recalled: Lack of Assurance of Sterility
Product: 0.9% Sodium Chloride Injection, USP, 50 mL x60, Becton, Dickson and Company, 1 Beckton Drive, Franklin Lakes, NJ 07417 USA, Distributed by BD, Manufactured by Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Sale NDC Number: 17271-701-02.
Where it went: US Nationwide , Alaska, and Puerto Rico.

0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 250 mL in a Single Dose freeflex bag, Rx

D-0431-2026 · Class II · reported 2026-04-15 · Ongoing

Why it was recalled: Lack of Assurance of Sterility
Product: 0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 250 mL in a Single Dose freeflex bag, Rx only, BD Becton, Dickson and Company, 1 Beckton Drive, Franklin Lakes, NJ 07417, Distributed by BD, Manufactured by: Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Sale NDC Number: 17271-701-05.
Where it went: US Nationwide , Alaska, and Puerto Rico.

0.9% Sodium Chloride Injection, USP 900 mg per 100 mL (9 mg per mL), 1,000 mL in a Single Dose freeflex bag, R

D-0434-2026 · Class II · reported 2026-04-15 · Ongoing

Why it was recalled: Lack of Assurance of Sterility
Product: 0.9% Sodium Chloride Injection, USP 900 mg per 100 mL (9 mg per mL), 1,000 mL in a Single Dose freeflex bag, Rx only, BD Becton, Dickson and Company, 1 Becton Drive, Franklin Lakes, NJ 07417, Distributed by BD, Manufactured by Fresenius Kabi, Unit of Sale NDC Number: 17271-701-07.
Where it went: US Nationwide , Alaska, and Puerto Rico.

0.9% SODIUM CHLORIDE Injection, USP, 100 mL, Rx only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, ND

D-0143-2026 · Class II · reported 2025-11-05 · Ongoing

Why it was recalled: Lack of Assurance of Sterility: Potential for flexible container leaks.
Product: 0.9% SODIUM CHLORIDE Injection, USP, 100 mL, Rx only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 0990-7984-37
Where it went: Distributed Nationwide in the USA.
How much: 509,360 100 mL bags

Class I

0.9% Sodium Chloride Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-35

D-0628-2025 · Class I · reported 2025-09-10 · Ongoing

Why it was recalled: Presence of Particulate Matter.
Product: 0.9% Sodium Chloride Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-7800-09
Where it went: U.S.A. Nationwide
How much: 47,148 containers

0.9% Sodium Chloride Injection USP, L 8000, 1000mL Excel Container, Rx Only, Sterile, nonpyrogenic, single dos

D-0586-2025 · Class II · reported 2025-08-20 · Ongoing

Why it was recalled: Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites.
Product: 0.9% Sodium Chloride Injection USP, L 8000, 1000mL Excel Container, Rx Only, Sterile, nonpyrogenic, single dose container, B. Braun Medical Inc., Bethlehem, PA 18018, NDC 0264-7800-00.
Where it went: Nationwide in the US
How much: 23,100 containers

0.9% Sodium Chloride Injection, USP, Flexible Plastic Container, Rx Only Fresenius Medical Care North America,

D-0490-2025 · Class II · reported 2025-07-02 · Ongoing

Why it was recalled: Lack of Assurance of Sterility
Product: 0.9% Sodium Chloride Injection, USP, Flexible Plastic Container, Rx Only Fresenius Medical Care North America, Waltham, MA 02451, 1-800-323-5188, NDC 49230-300-10
Where it went: Nationwide.
How much: 3,651,468 containers

0.9% Sodium Chloride Injection USP, 500 mL, packaged in 500 mL excel containers and further packaged 24 per ca

D-0491-2025 · Class II · reported 2025-07-02 · Ongoing

Why it was recalled: Lack of assurance of sterility: pinholes, within the finger boxes used during Form Fill Seal process resulting in leaks.
Product: 0.9% Sodium Chloride Injection USP, 500 mL, packaged in 500 mL excel containers and further packaged 24 per case, Rx only, B.Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC 0264-7800-10.
Where it went: USA Nationwide
How much: 187,656 containers

0.9% Sodium chloride Irrigation USP, Isotonic Solution for Irrigation, 500 mL Plastic Irrigation Container (PI

D-0353-2025 · Class II · reported 2025-04-16 · Ongoing

Why it was recalled: Presence of Particulate Matter
Product: 0.9% Sodium chloride Irrigation USP, Isotonic Solution for Irrigation, 500 mL Plastic Irrigation Container (PIC), B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-2201-10
Where it went: Product was distributed to 12 distributors who may have further distributed the product nationwide.
How much: 32,256 Bottles

Class I

0.9% Sodium Chloride Injection USP, E8000, 1000mL container, Rx only, B. Braun Medical Inc., Irvine, CA, NDC 0

D-0638-2024 · Class I · reported 2024-08-28 · Ongoing

Why it was recalled: Presence of Particulate Matter
Product: 0.9% Sodium Chloride Injection USP, E8000, 1000mL container, Rx only, B. Braun Medical Inc., Irvine, CA, NDC 0264-7800-09.
Where it went: Nationwide within U.S.A
How much: 63,444 containers

0.9% Sodium Chloride Injection USP, 1000 mL Excel Plus Container, Rx only, B. Braun Medical Inc. Bethlehem, PA

D-1083-2023 · Class III · reported 2023-08-16 · Terminated

Why it was recalled: Labeling: Not Elsewhere Classified - the description, warnings, storage information and instructions for use are either missing or partially printed.
Product: 0.9% Sodium Chloride Injection USP, 1000 mL Excel Plus Container, Rx only, B. Braun Medical Inc. Bethlehem, PA 18018, NDC 0264-5802-00
Where it went: United States
How much: 43,812 bags

0.9% Sodium Chloride Injection USP, 1000 mL Excel Plus Container, Rx only, B. Braun Medical Inc. Bethlehem, PA

D-0916-2023 · Class II · reported 2023-07-19 · Terminated

Why it was recalled: Lack of assurance of sterility: bags have the potential to leak.
Product: 0.9% Sodium Chloride Injection USP, 1000 mL Excel Plus Container, Rx only, B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA, NDC 0264-5802-00
Where it went: USA Nationwide
How much: 79,880 bags

Sodium Chloride 0.9% Injection, USP, 1000 mL bags, 12 bags per carton, Rx only, Fresenius Medical Care North A

D-0777-2023 · Class II · reported 2023-06-07 · Terminated

Why it was recalled: Lack of assurance of sterility: The product was potentially exposed to below-recommended storage temperatures, which may cause leaks in the packaging.
Product: Sodium Chloride 0.9% Injection, USP, 1000 mL bags, 12 bags per carton, Rx only, Fresenius Medical Care North America, Waltham, MA 02451, NDC # 49230-300-10
Where it went: Product was distributed to 32 clinics in SC, NC and VA.
How much: 53,424 bags

0.9% Sodium Chloride Injection, USP, 500 mL Excel Plus Container, Rx Only, B. Braun Medical Inc. Bethlehem, PA

D-0347-2023 · Class II · reported 2023-03-01 · Completed

Why it was recalled: Lack of sterility assurance: Recall of certain batches of 0.9% Sodium Chloride for Injection USP in EXCEL¿ Plus IV Container product due to the possibility of an incomplete seal that may cause leakage. The impacted lots may exhibit microscopic channel leaks near the port assembly of the product.
Product: 0.9% Sodium Chloride Injection, USP, 500 mL Excel Plus Container, Rx Only, B. Braun Medical Inc. Bethlehem, PA 18018, NDC 0264-5802-10
Where it went: USA Nationwide.
How much: 483,229 bags

0.9% Sodium Chloride Injection, USP, 1000 mL Excel Plus Container, Rx Only, B. Braun Medical Inc. Bethlehem, P

D-0346-2023 · Class II · reported 2023-03-01 · Completed

Why it was recalled: Lack of sterility assurance: Recall of certain batches of 0.9% Sodium Chloride for Injection USP in EXCEL¿ Plus IV Container product due to the possibility of an incomplete seal that may cause leakage. The impacted lots may exhibit microscopic channel leaks near the port assembly of the product.
Product: 0.9% Sodium Chloride Injection, USP, 1000 mL Excel Plus Container, Rx Only, B. Braun Medical Inc. Bethlehem, PA 18018, NDC 0264-5802-00
Where it went: USA Nationwide.
How much: 1,343,982 bags

0.9% Sodium Chloride Injection, USP, 100 mL Single-Dose Container bag, Rx Only, Nephron Pharmaceuticals Corpor

D-0177-2023 · Class II · reported 2023-02-01 · Terminated

Why it was recalled: CGMP Deviations: potential for trace amounts of product carryover.
Product: 0.9% Sodium Chloride Injection, USP, 100 mL Single-Dose Container bag, Rx Only, Nephron Pharmaceuticals Corporation, 4500 12th St. Extension, W. Columbia, SC 29172, NDC: 0487-4301-10, UPC 3 04874 30110 3.
Where it went: Nationwide in the USA
How much: 378 bags

0.9% Sodium Chloride Injection, USP, Each 100 mL contains: SODIUM CHLORIDE, USP - 900 mg, WATER FOR INJECTION,

D-0075-2023 · Class II · reported 2022-12-14 · Ongoing

Why it was recalled: Lack of Assurance of Sterility: Leakage of 0.9% Sodium Chloride for Injection, 1L, 12pk Saline Solution.
Product: 0.9% Sodium Chloride Injection, USP, Each 100 mL contains: SODIUM CHLORIDE, USP - 900 mg, WATER FOR INJECTION, USP - qs, 1000mL Bag, 12 PK, Rx Only, Fresenius Medical Care North America, Waltham, MA 02451, NDC 49230-300-10
Where it went: Product was distributed Nationwide in the USA.
How much: 4,097 cases/12 bags per case

0.9% Sodium Chloride Injection USP 1000 mL Single-dose container Rx only NDC 0264-5802-00 B. Braun Medical Inc

D-0076-2023 · Class II · reported 2022-12-14 · Terminated

Why it was recalled: Lack of sterility assurance: Bags have the potential to leak.
Product: 0.9% Sodium Chloride Injection USP 1000 mL Single-dose container Rx only NDC 0264-5802-00 B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA 1-800-227-2862
Where it went: FL, NJ, PA
How much: 756 bags

0.9% Sodium Chloride Injection, USP, 100 mL flexible container bag, Rx Only, ICU Medical, Inc., Lake Forest, I

D-0062-2023 · Class II · reported 2022-11-23 · Ongoing

Why it was recalled: Lack of assurance of sterility: Bags have the potential to leak in the flexible containers which may compromise sterility.
Product: 0.9% Sodium Chloride Injection, USP, 100 mL flexible container bag, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 0990-7984-37
Where it went: Nationwide in the USA
How much: 137,120 bags

0.9% Sodium Chloride Injection, USP, Each 100 mL contains: SODIUM CHLORIDE, USP - 900 mg, WATER FOR INJECTION,

D-0015-2023 · Class II · reported 2022-10-26 · Ongoing

Why it was recalled: Lack of Assurance of Sterility: Leakage of 0.9% Sodium Chloride for Injection, 1L, 12pk Saline Solution.
Product: 0.9% Sodium Chloride Injection, USP, Each 100 mL contains: SODIUM CHLORIDE, USP - 900 mg, WATER FOR INJECTION, USP - qs, 1000mL Bag, 12 PK, Rx Only, Fresenius Medical Care North America, Waltham, MA 02451, NDC 49230-300-10
Where it went: Nationwide in the USA
How much: 16,006 cases of twelve bags each

0.9% Sodium Chloride Injection USP, 250 mL Excel Container, Rx only, B. Braun Medical Inc., Bethlehem, PA, NDC

D-0655-2022 · Class II · reported 2022-03-23 · Terminated

Why it was recalled: Lack of sterility assurance: leaking bags
Product: 0.9% Sodium Chloride Injection USP, 250 mL Excel Container, Rx only, B. Braun Medical Inc., Bethlehem, PA, NDC 0264-7800-20
Where it went: USA Nationwide
How much: 33,742 bags

Showing the 30 most recent of 73. The rest are searchable at the FDA enforcement report database.

Read these counts with three things in mind

A firm with more recalls usually makes more products. A contract packer runs hundreds of lines. It will out-recall a company with one product whatever either does. This is not a safety ranking.

Most recalls here are voluntary. A firm found its own fault and pulled the stock. That is the system working. It lands in this database looking the same as a recall the FDA had to push for.

Terminated means the FDA considers the recall finished. It is not a verdict. It does not mean anyone was harmed.

Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.

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