B. Braun Medical Voluntarily Recalls Two Injections, Citing Presence of Particulate Matter

FDA announced on Aug. 19, 2025 that B. Braun Medical has recalled two lots of its Lactated Ringers Injection, USP, 1000 mL and 0.9% Sodium Chloride Injection, USP, 1000 mL, distributed nationwide up to the hospital level, due to what the company said is the presence of particulate matter inside the container (1).

Problems with particulate matter

Although there have been no reports thus far of serious injury, death, or other adverse events, and the recall is being conducted with FDA’s full knowledge, B. Braun said the discovery of particulate matter before use could cause at least a delay in finding a replacement product (1). However, if the matter becomes loose and the container is used on a patient, the company said there is a reasonable probability its use may cause pulmonary emboli, occlusions of other blood vessels, and/or phlebitis.

Foreign particles used intravenously have been known to result in systemic activation of the immune system, organ dysfunction, and hemolysis.

Dates distributed

B. Braun said the impacted lot (No. V3K770) of 0.9% Sodium Chloride Injection, USP, 1000 mL, indicated for extracellular fluid replacement and treatment of metabolic alkalosis in the presence of fluid loss as well as mild sodium depletion, was distributed between Nov. 15, 2023 and Sept. 25, 2024, and has an expiration date of Jan. 31, 2026 (1).

The affected lot (No. J4S807) of Lactated Ringers Injection, USP, 1000 mL, which is indicated for use in adults and pediatric patients as a source of electrolytes and water for hydration, was distributed from Dec. 26, 2024 to April 10, 2025 and carries an expiration date of May 31, 2027 (1).

How to handle recalled products

Both lots were distributed in packages that contained 12 products to a box; B. Braun said affected product should not be destroyed, but that “distributors that have affected product which is being recalled should determine their current inventory of the affected items within inventory of their facility, cease use and distribution, and quarantine product subject to recall” (1).

FDA said B. Braun is notifying distributors and customers of the recall by certified mail and will arrange for the return of all recalled products (1). Questions can be directed to B. Braun’s recalls department at 844-903-6417.

Additionally, adverse reactions or quality problems can be directed to FDA’s MedWatch Adverse Event Reporting program at this link, or by downloading the form or requesting it at 1-800-332-1088, then completing it and returning it either by mail to the address provided on the form, or by fax at 1-800-FDA-0178.

More on FDA recalls

Other recalls announced by FDA in 2025 include the following:

• Astellas Pharma US voluntarily recalled one lot of PROGRAF 0.5mg (tacrolimus) and one lot of ASTAGRAF XL 0.5mg (tacrolimus extended-release) capsules because some bottles may contain empty capsules. PROGRAF and ASTAGRAF XL are immunosuppressive drugs used to prevent organ transplant rejection (2).
• Provepharm voluntarily recalled one lot of Phenylephrine hydrochloride Injection, USP, 10 mg/mL (Pharmacy Bulk Package) because a customer found a visible black particulate matter in a single-sealed vial. Phenylephrine hydrochloride Injection is used to treat hypotension resulting from vasodilation in the setting of anesthesia (3).
• Alvogen voluntarily recalled one lot of Fentanyl Transdermal System 25 mcg/h transdermal patches because of the potential of multi-stacked patches. These patches are used to manage severe and persistent pain in opioid-tolerant patients for an extended treatment period with a daily opioid analgesic, and for patients who don’t respond well enough to alternative treatment options (4).
• Sandoz, Inc. voluntarily recalled one lot of cefazolin for injection, USP, 1 gram per vial after customers complained that four penicillin G potassium for injection, USP, 20 million units labeled vials were incorrectly included in a carton of Cefazolin for Injection vials. Cefazolin for injection is indicated for the treatment and/or prevention of bacterial infections in different parts of the body in adults, the elderly, and children (5).

References

1. FDA. B. Braun Medical Issues Voluntary Nationwide Recall of Lactated Ringers Injection USP 1000 mL and 0.9% Sodium Chloride Injection USP 1000 mL Due to the Presence of Particulate Matter. Press Release. Aug. 19, 2025.
2. Haigney, S. Astellas Pharma Recalls PROGRAF and ASTAGRAF XL Capsules. PharmTech.com, Jan. 2, 2025.
3. Haigney, S. Provepharm Recalls Phenylephrine Hydrochloride Injection. PharmTech.com, Jan. 27, 2025.
4. Haigney, S. Alvogen Recalls Fentanyl Transdermal System. PharmTech.com, Feb. 3, 2025.
5. Haigney, S. Sandoz Recalls Cefazolin Due to Mispackaging, Opens Biosimilar Facility in Slovenia. PharmTech.com, July 2, 2025.