thejoe Baxter Healthcare Corp.

Baxter Healthcare Corp.: 58 FDA recall reports

Every drug recall the FDA has published for Baxter Healthcare Corp.. The fault, and how the agency graded it.

58Reports

24Class I

0Ongoing

2016-06-15Most recent

24 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	34
Class I	24

By year reported

Year	Reports
2012	5
2013	9
2014	22
2015	14
2016	8

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.

Class I

0.9% Sodium Chloride Injection, USP, 250 mL VIAFLEX Plastic Container Bag, Rx Only, Manufactured by Baxter Hea

D-0957-2016 · Class I · reported 2016-06-15 · Terminated

Why it was recalled: Presence of Particulate Matter: Confirmed customer compliants of finding an insect floating in the primary container of each product.
Product: 0.9% Sodium Chloride Injection, USP, 250 mL VIAFLEX Plastic Container Bag, Rx Only, Manufactured by Baxter Healthcare Corporation, Deerfield, IL 60015, NDC 0338-0049-02
Where it went: Nationwide
How much: 255,852 VIAFLEX Plastic Containers

Class I

Dextrose Injection,USP,70% 2000 mL VIAFLEX Plastic Container Bag, Pharmacy Bulk Package, Not For Direct Infusi

D-0958-2016 · Class I · reported 2016-06-15 · Terminated

Why it was recalled: Presence of Particulate Matter: Confirmed customer compliants of finding an insect floating in the primary container of each product.
Product: Dextrose Injection,USP,70% 2000 mL VIAFLEX Plastic Container Bag, Pharmacy Bulk Package, Not For Direct Infusion, Must Be Diluted, Rx Only, Manufactured by Baxter Healthcare Corporation, Deerfield, IL 60015, NDC 0338-0719-06
Where it went: Nationwide
How much: 28,080 VIAFLEX Plastic Containers

Class I

Metronidazole Injection USP, 500 mg per 100 mL (5 mg/mL), 100mL Sterile Single Dose Container bag, Rx only, Ba

D-0863-2016 · Class I · reported 2016-06-01 · Terminated

Why it was recalled: Presence of Particulate Matter: identified as a cloth fiber.
Product: Metronidazole Injection USP, 500 mg per 100 mL (5 mg/mL), 100mL Sterile Single Dose Container bag, Rx only, Baxter USA, Product Code 2B3421, NDC 0338-1055-48.
Where it went: Nationwide and Puerto Rico
How much: 334,560 bags

Class I

0.9% Sodium Chloride Injection USP, MINI-BAG Plus Container, 100 mL VIAFLEX Single Dose Container bags, Rx onl

D-0862-2016 · Class I · reported 2016-06-01 · Terminated

Why it was recalled: Presence of Particulate Matter: identified as cardboard.
Product: 0.9% Sodium Chloride Injection USP, MINI-BAG Plus Container, 100 mL VIAFLEX Single Dose Container bags, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product Code 2B0043, NDC 0338-0553-18.
Where it went: Nationwide and Puerto Rico
How much: 273,520 bags

0.9% Sodium Chloride Injection USP, MINI-BAG Plus Container, 100 mL VIAFLEX Single Dose Container bags, Rx onl

D-0861-2016 · Class II · reported 2016-06-01 · Terminated

Why it was recalled: Lack of Assurance of Sterility: potential for leaking containers which lacks the assurance of sterility.
Product: 0.9% Sodium Chloride Injection USP, MINI-BAG Plus Container, 100 mL VIAFLEX Single Dose Container bags, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product Code 2B0043, NDC 0338-0553-18.
Where it went: Nationwide and Puerto Rico
How much: 282,080 bags

Class I

CLINIMIX E 5/15 sulfite-free (5% Amino Acid with Electrolytes in 15% Dextrose with Calcium) Injection, 1000 mL

D-0864-2016 · Class I · reported 2016-06-01 · Terminated

Why it was recalled: Presence of Particulate Matter: identified as dried skin.
Product: CLINIMIX E 5/15 sulfite-free (5% Amino Acid with Electrolytes in 15% Dextrose with Calcium) Injection, 1000 mL Injection Port Chamber 30% Dextrose Injection with Calcium, 1000 mL Outlet Port Chamber 10% Amino Acid Injection with Electrolytes, 2000 mL CLARITY Dual Chamber Container bag, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product Code 2B7721, NDC 0338-1123-04.
Where it went: Nationwide and Puerto Rico
How much: 7,436 bags

Brevibloc DOUBLE STRENGTH Premixed Injection, Esmolol Hydrochloride in Sodium Chloride, 2000mg/100mL (20 mg/mL

D-0852-2016 · Class II · reported 2016-05-18 · Terminated

Why it was recalled: Discoloration: presence of atypical yellow discoloration of the solution .
Product: Brevibloc DOUBLE STRENGTH Premixed Injection, Esmolol Hydrochloride in Sodium Chloride, 2000mg/100mL (20 mg/mL), 100 mL, Rx only, Manufactured by Baxter Healthcare Corporation, Deerfield, Il 60015, NDC 10019-075-87
Where it went: Nationwide
How much: 11,630 babs

0.9% Sodium Chloride Irrigation, USP, 500 mL bottle, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 600

D-0731-201 · Class II · reported 2016-03-09 · Terminated

Why it was recalled: PRESENCE OF PARTICULATE MATTER: Product complaint for the presence of particulate matter identified as an insect.
Product: 0.9% Sodium Chloride Irrigation, USP, 500 mL bottle, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product code 2F7123, NDC 0338-0048-03
Where it went: Nationwide and Puerto Rico
How much: 257,364 bottles

Class I

0.9% Sodium Chloride Injection USP, 50 mL Single Dose VIAFLEX Container bags, Rx only, Baxter Healthcare Corpo

D-1336-2015 · Class I · reported 2015-08-26 · Terminated

Why it was recalled: Presence of Particulate Matter: Customer complaint for an insect found free floating inside a single bag for each lot recalled.
Product: 0.9% Sodium Chloride Injection USP, 50 mL Single Dose VIAFLEX Container bags, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product Code 2B1301, NDC 0338-0049-11.
Where it went: Nationwide
How much: 189,120 bags

Class I

0.9% Sodium Chloride Injection USP MINI-BAG Plus Container, 100 mL VIAFLEX Single Dose Container bags, Rx only

D-1335-2015 · Class I · reported 2015-08-26 · Terminated

Why it was recalled: Presence of Particulate Matter: Customer complaint for an insect found free floating inside a single bag for each lot recalled.
Product: 0.9% Sodium Chloride Injection USP MINI-BAG Plus Container, 100 mL VIAFLEX Single Dose Container bags, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product Code 2B0043, NDC 0338-0553-18.
Where it went: Nationwide
How much: 133,600 bags

0.9% Sodium Chloride Injection USP, 500 mL in VIAFLEX Plastic Container, Baxter Healthcare Corporation Deerfie

D-1326-2015 · Class II · reported 2015-08-19 · Terminated

Why it was recalled: Presence of Particulate Matter and Lack of Assurance of Sterility: The firm received a complaint for customer of presence of particulate matter, leaky containers, and missing port protectors.
Product: 0.9% Sodium Chloride Injection USP, 500 mL in VIAFLEX Plastic Container, Baxter Healthcare Corporation Deerfield, IL 60015, NDC 0338-0049-03.
Where it went: TX and TN
How much: 189,912 containers

Class I

0.9% Sodium Chloride Injection, USP, in 250mL VIAFLEX Plastic bags, Manufactured by Baxter Healthcare Corporat

D-1208-2015 · Class I · reported 2015-07-15 · Terminated

Why it was recalled: Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal)
Product: 0.9% Sodium Chloride Injection, USP, in 250mL VIAFLEX Plastic bags, Manufactured by Baxter Healthcare Corporation 65 Pitts Station Road Marion, North Carolina 28752-7925 for Baxter Healthcare Corporation 1 Baxter Pkwy Deerfield, IL 60015-4625. NDC 0338-0049-02
Where it went: US, Puerto Rico, and Bermuda
How much: 202,824 Bags

Class I

5% Dextrose Injection, USP, 250mL VIAFLEX Plastic bags, Manufactured by Baxter Healthcare Corporation 65 Pitts

D-1209-2015 · Class I · reported 2015-07-15 · Terminated

Why it was recalled: Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal)
Product: 5% Dextrose Injection, USP, 250mL VIAFLEX Plastic bags, Manufactured by Baxter Healthcare Corporation 65 Pitts Station Road Marion, North Carolina 28752-7925 for Baxter Healthcare Corporation 1 Baxter Pkwy Deerfield, IL 60015-4625. NDC 0338-0017-02
Where it went: US, Puerto Rico, and Bermuda
How much: 402,284 bags

Class I

Lactated Ringers Injection, USP, 250mL VIAFELX Plastic bags, Manufactured by Baxter Healthcare Corporation 65

D-1211-2015 · Class I · reported 2015-07-15 · Terminated

Why it was recalled: Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal)
Product: Lactated Ringers Injection, USP, 250mL VIAFELX Plastic bags, Manufactured by Baxter Healthcare Corporation 65 Pitts Station Road Marion, North Carolina 28752-7925 for Baxter Healthcare Corporation 1 Baxter Pkwy Deerfield, IL 60015-4625. NDC 0338-0117-02
Where it went: US, Puerto Rico, and Bermuda
How much: 58,932 bags

Class I

10% Dextrose Injection, USP, 250mL VIAFLEX Plastic bags, Manufactured by Baxter Healthcare Corporation 65 Pit

D-1210-2015 · Class I · reported 2015-07-15 · Terminated

Why it was recalled: Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal)
Product: 10% Dextrose Injection, USP, 250mL VIAFLEX Plastic bags, Manufactured by Baxter Healthcare Corporation 65 Pitts Station Road Marion, North Carolina 28752-7925 for Baxter Healthcare Corporation 1 Baxter Pkwy Deerfield, IL 60015-4625. NDC 0338-0023-02
Where it went: US, Puerto Rico, and Bermuda
How much: 18,324 bags

Heparin Sodium and 0.9% Sodium Chloride Injection, 1000 USP Heparin Units, 500 mL in a VIAFLEX Plus Container,

D-1131-2015 · Class II · reported 2015-06-17 · Terminated

Why it was recalled: Subpotent Drug; out of specification results for heparin raw material
Product: Heparin Sodium and 0.9% Sodium Chloride Injection, 1000 USP Heparin Units, 500 mL in a VIAFLEX Plus Container, Rx Only, Baxter Healthcare Corporation, Deerfield, IL --- NDC 0338-0431-03
Where it went: Nationwide
How much: 145,350 containers

Class I

0.9% Sodium Chloride Injection USP, 100 mL MINI-BAG Plus Container, Rx only, Baxter Healthcare Corporation, De

D-481-2015 · Class I · reported 2015-04-15 · Terminated

Why it was recalled: Presence of Particulate Matter: Confirmed customer complaints received for the presence of blue plastic, identified as fragments of the frangible from the vial adapter.
Product: 0.9% Sodium Chloride Injection USP, 100 mL MINI-BAG Plus Container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, USA, Product Code 2B0043, NDC 0338-0553-18.
Where it went: Nationwide and Puerto Rico.
How much: 542,080 container bags

0.9% Sodium Chloride Injection, USP, 50 mL, VIAFLEX Plastic Container Multi Pack, Rx Only, Baxter Healthcare C

D-0429-2015 · Class II · reported 2015-04-08 · Terminated

Why it was recalled: Lack of Assurance of Sterility; increased complaints received for leaks
Product: 0.9% Sodium Chloride Injection, USP, 50 mL, VIAFLEX Plastic Container Multi Pack, Rx Only, Baxter Healthcare Corporation, Deerfield, IL , Product code 2B1308, NDC 0338-0049-31
Where it went: Nationwide and Singapore
How much: 196,128 containers

Clinimix E 5/20 sulfite-free (5% amino-acid with electrolytes in 20% dextrose with calcium) Injection, 2000 mL

D-0428-2015 · Class II · reported 2015-04-08 · Terminated

Why it was recalled: Lack of Assurance of Sterility; increased complaints received for leaks
Product: Clinimix E 5/20 sulfite-free (5% amino-acid with electrolytes in 20% dextrose with calcium) Injection, 2000 mL in Dual Chamber Container, Rx Only, Baxter Healthcare Corporation, Deerfield, IL --- Product code 2B7722, NDC 0338-1125-04
Where it went: Nationwide and Singapore
How much: 7444 containers

5% Dextrose Injection, USP, 1000mL in VIAFLEX Plastic Container, Rx only, Manufactured by Baxter Healthcare Co

D-0426-2015 · Class II · reported 2015-04-01 · Terminated

Why it was recalled: Lack of Assurance of Sterility. Complaints were receive of missing closures and/or leaks which may compromise product sterility.
Product: 5% Dextrose Injection, USP, 1000mL in VIAFLEX Plastic Container, Rx only, Manufactured by Baxter Healthcare Corp., North Cove, North Carolina Facility Highway 221 North, Marion, NC 28752 for Baxter Healthcare Corporation, One Baxter Parkway, Deerfield, IL 60015. NDC 0338-0017-04
Where it went: Nationwide
How much: 48,874

0.9% Sodium Chloride Injection, USP, 500 mL in VIAFLEX Plastic Container, Rx only, Manufactured by Baxter Heal

D-0425-2015 · Class II · reported 2015-04-01 · Terminated

Why it was recalled: Lack of Assurance of Sterility. Complaints were receive of missing closures and/or leaks which may compromise product sterility.
Product: 0.9% Sodium Chloride Injection, USP, 500 mL in VIAFLEX Plastic Container, Rx only, Manufactured by Baxter Healthcare Corp., North Cove, North Carolina Facility Highway 221 North, Marion, NC 28752 for Baxter Healthcare Corporation, One Baxter Parkway, Deerfield, IL 60015. NDC 0338-0049-03
Where it went: Nationwide
How much: 597,498 units total

Fluconazole Injection, USP, 200 mg/100 mL (2 mg/mL), 100 mL Single-Dose INTRAVIA Container bag, packaged in 10

D-0380-2015 · Class II · reported 2015-02-04 · Terminated

Why it was recalled: Lack of Assurance of Sterility: Complaints of leaks due to an incomplete seal at the bag seam.
Product: Fluconazole Injection, USP, 200 mg/100 mL (2 mg/mL), 100 mL Single-Dose INTRAVIA Container bag, packaged in 10 x 100 mL Single Dose INTRAVIA container bags per carton, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-6046-48, Product Code 2J1446.
Where it went: Nationwide, United Arab Emirates, and Columbia
How much: 31,130 bags

Clinimix E 4.25/10 sulfite-free (4.25% Amino Acid with Electrolytes in 10% Dextrose with Calcium) Injections,

D-0301-2015 · Class II · reported 2014-12-24 · Terminated

Why it was recalled: Lack of Assurance of Sterility; leaks were observed from the bag seam and port seal
Product: Clinimix E 4.25/10 sulfite-free (4.25% Amino Acid with Electrolytes in 10% Dextrose with Calcium) Injections, in CLARITY Dual Chamber Container, Baxter Healthcare Corporation, Deerfield, IL NDC 0338-1115-04
Where it went: Nationwide
How much: 7,220 bags

Famotidine Injection 20 mg, Rx Only, GALAXY Single Dose Container, Code 2G3424, Sterile Nonpyrogenic, 50 mL Is

D-0293-2015 · Class II · reported 2014-12-17 · Terminated

Why it was recalled: Presence of Particulate Matter: Baxter Healthcare Corporation has received a complaint reporting the presence of particulate matter identified as plastic/rubber in famotidine Injection premixed containers.
Product: Famotidine Injection 20 mg, Rx Only, GALAXY Single Dose Container, Code 2G3424, Sterile Nonpyrogenic, 50 mL Iso-osmotic, Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-5197-41.
Where it went: Nationwide
How much: 19,152 Containers

Potassium Chloride Injection, 10mEq per 100mL, 100 mL Sterile single dose container bags, Rx only, Baxter USA,

D-0256-2015 · Class II · reported 2014-12-03 · Terminated

Why it was recalled: Labeling: Label Error On Declared Strength: Bags of Potassium Chloride 10 mEq per 100 mL were incorrectly overpouched with wraps labeled as Potassium Chloride Injection, 20 mEq per 100 mL.
Product: Potassium Chloride Injection, 10mEq per 100mL, 100 mL Sterile single dose container bags, Rx only, Baxter USA, NDC 0338-0709-48, Product Code 2B0826.
Where it went: Nationwide
How much: 63,360 container bags

Heparin Sodium in 0.9% Sodium Chloride Injection, 1000 USP Heparin Units, 500 mL in a VIAFLEX Plus Container,

D-0276-2015 · Class II · reported 2014-12-03 · Terminated

Why it was recalled: Subpotent Drug: Heparin raw material was found to have low potency
Product: Heparin Sodium in 0.9% Sodium Chloride Injection, 1000 USP Heparin Units, 500 mL in a VIAFLEX Plus Container, Rx only, Manufactured for Baxter Healthcare Corporation, One Baxter Parkway, Deerfield, IL 60015 by Baxter Healthcare Corporation 250 Road 144 Jayuya, Puerto Rico, 00664, NDC 0338-0431-03
Where it went: Nationwide
How much: 127,746 Viaflex Plus Container

Class I

Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose, 5000 mL Ambu-Flex II containe

D-1610-2014 · Class I · reported 2014-10-08 · Terminated

Why it was recalled: Presence of Particulate Matter: particulate matter was found during the manufacturing process.
Product: Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose, 5000 mL Ambu-Flex II container bags, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015; Product Code L5B5202, NDC 0941-0457-05.
Where it went: Nationwide
How much: 50,530 bags

DOPamine Hydrochloride and 5% Dextrose INJ, USP, 200 mg per 250 mL, Rx Only, Baxter USA, NDC 0338-1005-02.

D-0004-2015 · Class II · reported 2014-10-08 · Terminated

Why it was recalled: Lack of Assurance of Sterility: A small cut in the solution bag may have been introduced during the manufacturing process, resulting in a leak of the bag into the overpouch.
Product: DOPamine Hydrochloride and 5% Dextrose INJ, USP, 200 mg per 250 mL, Rx Only, Baxter USA, NDC 0338-1005-02.
Where it went: Nationwide and Canada
How much: 11,808 bags

Potassium Chloride Injection, 10 mEq per 100 mL, Highly Concentrated (100 mEq/L), 100 mL Sterile single dose c

D-1606-2014 · Class II · reported 2014-10-01 · Terminated

Why it was recalled: Correct Labeled Product Mispack: Shipping cartons labeled as containing Potassium Chloride injection actually contained bags labeled and containing Gentamicin Sulfate injection inside.
Product: Potassium Chloride Injection, 10 mEq per 100 mL, Highly Concentrated (100 mEq/L), 100 mL Sterile single dose container bags, Rx only, Baxter USA, product code 2B0826, NDC 0338-0709-48.
Where it went: Nationwide
How much: 148632 bags

Class I

0.9% Sodium Chloride Injection USP MINI-BAG Plus Container, 100 mL VIAFLEX Single Dose Container bags, Rx only

D-1592-2014 · Class I · reported 2014-09-24 · Terminated

Why it was recalled: Presence of Particulate Matter: particulate matter identified as fibers and/or plastics.
Product: 0.9% Sodium Chloride Injection USP MINI-BAG Plus Container, 100 mL VIAFLEX Single Dose Container bags, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-0553-18, Product Code 2B0043.
Where it went: Nationwide, Puerto Rico, Singapore, and Hong Kong
How much: 390,560 bags

Showing the 30 most recent of 58. 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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