Merck has discontinued Recarbrio, an intravenous antibiotic reserved for serious hospital infections with few treatment options, in the United States. A drug shortage notice for Recarbrio posted Sept. 9 lists the product as discontinued, with supply expected to end on or near late September. STAT reported on Sept. 28 that the company had not explained the decision.
The patients affected are a small but vulnerable group. Recarbrio is approved for pneumonia that develops in a hospital or on a ventilator, and for complicated urinary tract and abdominal infections, in patients with limited or no other treatment options. It is not used for ordinary bladder infections treated with pills.
In a statement to CIDRAP News, Merck said the decision was not related to safety or quality problems. "Alternative therapeutic options remain available for the approved indications; patients should consult their healthcare provider to determine the appropriate course of action," the company said.
Who Received Recarbrio and What Doctors Can Use Instead
Recarbrio combines three ingredients: the antibiotic imipenem; cilastatin, which keeps the kidneys from breaking down imipenem; and relebactam, which blocks enzymes some bacteria use to destroy antibiotics. In adults, it is given by IV infusion over 30 minutes every six hours, according to its FDA approval history and prescribing details. The FDA approved it in 2019 for complicated urinary tract and abdominal infections and in 2020 for hospital-acquired and ventilator-associated bacterial pneumonia. The label was expanded to children in 2025.
Relebactam was designed to overcome an enzyme called KPC, which lets some bacteria resist carbapenems, a class of powerful antibiotics often held in reserve. These carbapenem-resistant infections mostly affect people who are already seriously ill in hospitals.
Doctors still have other choices. Dr. Amesh Adalja, an infectious disease physician at the Johns Hopkins University Center for Health Security, told CIDRAP that ceftazidime-avibactam, meropenem-vaborbactam, and cefiderocol remain available for KPC-producing infections. Doctors choose among these drugs based on lab tests that show which antibiotics still work against a patient's specific bacteria.
The discontinuation applies to Recarbrio only. Imipenem-cilastatin without relebactam, an older antibiotic first sold by Merck as Primaxin and now also made by generic manufacturers, is a separate product. Relebactam is what extended Recarbrio's reach against certain resistant bacteria.
Common side effects of Recarbrio include diarrhea, nausea, headache, and vomiting. The drug also carries warnings about seizures, including a higher risk in patients taking the seizure medicine valproic acid. Any replacement antibiotic has its own side effects, which the care team should explain.
A Gap Doctors Call Narrow but Real
Adalja described the clinical gap as "immediate but narrow." "The loss will be felt most with difficult-to-treat Pseudomonas aeruginosa, where imipenem-relebactam was one of a short list of preferred options," he told CIDRAP. Pseudomonas infections most often affect hospitalized patients, especially those on ventilators or with weakened immune systems.
Not every expert sees a major loss. Dr. Brad Spellberg, chief medical officer at Los Angeles General Medical Center, told CIDRAP he was not surprised by the withdrawal. He said the drug was "not in any way meaningfully differentiated from multiple other drugs on the market."
The withdrawal comes as resistance continues to spread. MedicalDaily previously reported that CDC surveillance found a 461% rise in NDM infections, a type of carbapenem-resistant infection, from 2019 through 2023. Because resistance patterns vary by region, the practical effect of losing Recarbrio may differ from one hospital to the next.
A Market Problem That Reaches Beyond One Drug
The larger concern is why a newer antibiotic was pulled at all. STAT noted that the FDA positioned Recarbrio as a treatment of last resort to help slow resistance, which also limits sales, and that Merck did not report the drug's sales in its financial filings.
Henry Skinner, CEO of the AMR Action Fund, told CIDRAP that holding back new antibiotics is the right approach but carries a cost. "We appropriately reserve new antibiotics for patients who truly need them, but that means these medicines will sit on the shelf for long periods and generate little revenue," he said. He was especially concerned about children, noting that Merck had completed costly pediatric studies to extend the label to children weighing as little as 2 kilograms (about 4.4 pounds).
Adalja and Skinner both pointed to the PASTEUR Act, a bill that would pay companies fixed annual amounts for important new antibiotics regardless of how often they are used. The bipartisan PASTEUR Act was reintroduced in the Senate in June 2026. It was first introduced in 2020 and has not become law.
Steps for Patients and Families During a Hospital Stay
Families with a loved one currently receiving Recarbrio can ask the care team whether the hospital has enough supply to finish the course and what the backup plan is. Doctors can switch to another drug based on lab results, and a switch does not necessarily mean worse care. For complex, resistant infections, it is reasonable to ask whether an infectious disease specialist is involved.
Patients and caregivers can also ask the care team to explain lab results in plain language. Signs that an infection may be getting worse include new or rising fever, chills, confusion, fast breathing, or a racing heart. Report these to a nurse right away, since they can signal sepsis.
The FDA's drug shortage database lets anyone check the status of specific medicines, including discontinued products.
Key Questions Answered
What happened to Recarbrio?
Merck discontinued the IV antibiotic in the United States, with supply expected to end on or near late September 2026. The company told CIDRAP the decision was not related to safety or quality problems.
Who used it?
Hospitalized adults and children with hospital-acquired or ventilator-associated pneumonia, complicated urinary tract infections, or complicated abdominal infections who had few other treatment options.
Are there alternatives?
Yes. Depending on lab results, doctors can use drugs such as ceftazidime-avibactam, meropenem-vaborbactam, and cefiderocol.
Who could be most affected?
Patients with difficult-to-treat Pseudomonas aeruginosa infections, for which the drug was one of a short list of preferred options.
Does this affect ordinary UTIs?
No. Recarbrio was a hospital IV drug, not a pill for routine bladder infections.
What should families ask?
Whether enough supply remains to finish treatment, what the backup drug is, and whether an infectious disease specialist is involved.
Published by Medicaldaily.com
