7 lots of Baxter and B. Braun IV solutions recalled over particulate matter

What was recalled: four notices, seven lots

FDA posted four company announcements in the last week of August 2026 involving IV fluids from two large hospital suppliers. They are separate recalls with separate lot numbers, but the theme is the same: particulate matter in a solution meant for a vein.

• B. Braun Medical Inc. (release dated Aug. 19, 2026; posted by FDA Aug. 28): three lots of 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB container, recalled to the hospital, healthcare facility and user level.
• Baxter (Aug. 25, 2026; posted Aug. 26): two lots of 0.9% Sodium Chloride Injection, USP, 500 mL VIAFLEX Plastic Container, packaged 24 units per case.
• Baxter (Aug. 25, 2026): one lot of 70% Dextrose Injection, USP in 2000 mL VIAFLEX Plastic Container, a pharmacy bulk package not for direct infusion, 6 units per case.
• Baxter (Aug. 25, 2026): one lot of Anticoagulant Sodium Citrate Solution USP, 250 mL VIAFLEX Plastic Container, 36 units per case, for use only with automated apheresis devices.

According to the notices, all four were distributed to hospitals, healthcare facilities, providers or distributors, not to consumers. Other August 2026 drug recalls that did reach consumers directly, such as the Vitruvias thyroid tablets recall and the Lipofit Extreme fat burner recall, are covered separately.

Why they were recalled: particles in the solution

Each notice names a different material.

• B. Braun 100 mL saline: particulate matter identified as iron oxide.
• Baxter 500 mL saline: potential presence of particulate matter identified as fiberglass.
• Baxter 70% dextrose: potential presence of particulate matter identified as stainless steel particles.
• Baxter sodium citrate: potential presence of particulate matter identified as fiberglass.

The companies' risk statements explain why this matters. B. Braun says administration of saline containing particulate matter has a reasonable probability of causing life-threatening adverse health consequences, including pulmonary emboli, occlusions of other blood vessels and phlebitis, and that foreign particles infused intravenously can cause systemic activation of the immune system, organ dysfunction and hemolysis. Baxter's saline and dextrose notices say particulate matter can cause blockage and clotting in blood vessels, cut off blood flow to vital organs, lead to a life-threatening blood clot in the lungs and cause permanent organ damage or death. For the citrate solution, Baxter says the extent and severity of harm depend on the size, number, morphology and composition of the material, and that without in-line filtration the particles may cause vein irritation, inflammatory or hypersensitivity reactions and systemic embolization.

Where the products went

These are hospital and clinic supplies, and the distribution windows were short.

• B. Braun 100 mL saline: distributed nationwide to hospitals and healthcare facilities from Feb. 27, 2026 to Aug. 3, 2026.
• Baxter 500 mL saline: distributed from July 31 to Aug. 3, 2026 to healthcare providers and distributors in select states, including Florida, Illinois, Indiana, Louisiana, Maryland, Missouri, North Carolina, New Jersey, Nevada, New York, Ohio, South Carolina, Texas and Virginia.
• Baxter 70% dextrose: distributed from July 25 to July 28, 2026 to healthcare providers and distributors in select states, including Alabama, Georgia and Tennessee.
• Baxter sodium citrate: distributed from July 2 to July 11, 2026 to one customer in the United States.

One exception is home parenteral nutrition. Baxter's dextrose notice says homecare facilities that used the lot to compound parenteral nutrition solutions should contact their patients to alert them to discontinue using the solutions and replace them with ones not compounded with the affected lot.

How to identify the affected lots

Lot numbers and expiration dates are printed on the individual product and on the shipping carton, according to the Baxter notices, and B. Braun's table lists the same identifiers alongside its catalog number. Facilities check these against their stock; patients generally will not see them unless they ask for the lot number recorded in their chart or printed on a home-infusion label. Other lots of the same products are not included: B. Braun's recall is limited to the three lots below, and Baxter's saline, dextrose and citrate recalls each name only the lots shown.

Reported adverse events

None had been reported when the notices were issued. B. Braun's announcement states: "To date there have been no reports of serious injury, death or other adverse events associated with this issue." Each of the three Baxter notices states that as of Aug. 25, 2026, Baxter had not received any reports of adverse events related to the issue.

That is a snapshot at the time of the announcement. All four notices ask that adverse reactions or quality problems be reported to FDA's MedWatch program, online at www.fda.gov/medwatch/report.htm or by calling 1-800-332-1088 to request a form.

For patients who had an infusion or apheresis procedure in the affected windows, the notices' advice is the same across all four: contact your physician or healthcare provider if you have experienced any problems that may be related to the product.

What facilities and patients should do

The remedies are written for hospitals and distributors, in the companies' words:

• B. Braun: "B. Braun is notifying its distributors and customers by mail and is arranging for return and replacement of all recalled products. Customers that have the recalled product should return to place of purchase." Questions: recalls@bbraunusa.com, Monday to Friday, 8:00 a.m. to 5:00 p.m. EST.
• Baxter (all three notices): "Customers should immediately discontinue use of and return all affected units in accordance with their facility's process." Questions: Baxter Healthcare Center for Service, 888-229-0001, 7:00 a.m. to 6:00 p.m. Central Time, Monday through Friday.

For patients, the notices add one line: consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using the drug product. There is nothing for a patient to return, and no consumer refund is described, because the products were never sold to consumers.

1. Facilities and distributors: set aside stock matching the lot numbers in the table, stop using it, and follow the company's return instructions.
2. Home parenteral nutrition patients: if your solutions were compounded with Baxter 70% Dextrose lot Y495066, your homecare provider should contact you; stop using them and replace them as instructed.
3. Patients who had an infusion or apheresis in the affected windows and feel unwell: contact your physician or healthcare provider, as the notices advise.
4. Report adverse reactions or quality problems to FDA MedWatch online or by calling 1-800-332-1088.
5. Questions about a specific lot: B. Braun at recalls@bbraunusa.com; Baxter at 888-229-0001.

Who issued the notices and when

All four are company-initiated recalls whose announcements FDA posted on its Recalls, Market Withdrawals and Safety Alerts page.

• B. Braun Medical Inc., Bethlehem, Pa.: release dated Aug. 19, 2026; company announcement date Aug. 27, 2026; FDA publish date Aug. 28, 2026. The notice says the recall is being conducted with the knowledge of the FDA, and the reason was updated on Aug. 28 to identify iron oxide rather than zinc oxide.
• Baxter International Inc., Deerfield, Ill., 0.9% Sodium Chloride 500 mL: announced Aug. 25, 2026; FDA publish date Aug. 26, 2026.
• Baxter, 70% Dextrose Injection: announced and published Aug. 25, 2026.
• Baxter, Anticoagulant Sodium Citrate Solution: announced and published Aug. 25, 2026.

None of the four announcements lists an FDA recall classification (Class I, II or III) or a recall number. FDA publishes those later in its Enforcement Reports; as of Sept. 1, 2026, the openFDA drug enforcement database had no entries for these lots.

How to monitor recalls and why to keep your receipts

Drug and device recalls are listed on FDA's Recalls, Market Withdrawals and Safety Alerts page. For other categories, check cpsc.gov/Recalls for consumer products, nhtsa.gov/recalls for a VIN lookup on vehicles, USDA FSIS for meat and poultry, and FoodSafety.gov for food alerts; retailer notifications and the brand's own site fill the gaps.

For hospital-administered products, discharge summaries, infusion records and home-infusion labels carry the product and lot number. Keep them, along with receipts and photos of packaging with lot codes for anything you buy yourself. That proof may matter if a company reimbursement or a future claim program becomes available. Owed tracks open class action settlements, not recalls; see the current list.

Glossary

Particulate matter

Foreign solid material in a solution that is meant to be sterile and particle-free; in these notices, iron oxide, fiberglass or stainless steel particles.

Lot number

The batch identifier printed on the container and shipping carton (for example Y495523). Recalls are defined by lot, so other lots of the same product are not affected.

NDC

National Drug Code, the FDA identifier for a specific drug product and package size, such as 0338-0049-03 for Baxter's 500 mL saline.

Pharmacy bulk package

A container, like the 2000 mL 70% dextrose bag, meant for a pharmacy to draw from when preparing admixtures; it is labeled not for direct infusion.

Apheresis

A procedure in which blood is drawn through a machine that separates out a component and returns the rest; the sodium citrate solution is intended for use only with those devices.

MedWatch

FDA's program for reporting adverse events and product quality problems, online at fda.gov/medwatch or by phone at 1-800-332-1088.

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