Cold medicines being withdrawn include: Johnson & Johnson Pediacare Infant Drops and Tylenol Concentrated Infants Drops, Wyeth's Dimetapp Decongestant Infant Drops, Novartis' Triaminic Infant & Toddler Thin Strips and Prestige Brands Holdings' Little Colds Decongestant Plus Cough.
A spokeswoman for the Consumer Healthcare Products Association, a trade group representing makers of over-the-counter medicines, said overdoses have led to death and serious injury in rare instances, but stressed the medications are safe when used as directed, according to a Reuters report.
Late last month, the Food and Drug Administration tentatively recommended adding the words "do not use in children under two years" to product labeling for kids' cold medications. The FDA will not make a final decision on whether to change the warnings or labels on the widely used drugs until it gets input from advisers at a meeting scheduled for Oct. 18-19.
The medicine recall comes soon after a new report on the troubled state of children's health care.
According to a study published Wednesday in the New England Journal of Medicine, U.S. children, even those with health insurance, are getting the medical care they need less than half the time.
The study showed lapses in basic preventative care such as monitoring height and weight, providing immunizations and care for acute conditions like infections or chronic conditions like asthma.
"Before this study was done, most people thought kids were getting reasonably good care," study lead author Dr. Rita Mangione-Smith told ABC News. "I have to say that, as a pediatrician, I was surprised that things were as bad as they were."
Mangione-Smith, a researcher at Seattle Children's Hospital, and her colleagues examined the medical records of more than 1,500 children from 12 cities. Then they compared those records to a set of 175 quality care indicators based on national care guidelines and the opinions of an expert group of pediatricians.
They found that, overall, children received only 46.5 percent of recommended care.
Preventative care, such as immunizations and regular height and weight measurements, fared worst - children received these services only 40.7 percent of the time.
Care for chronic conditions, such as tracking asthma treatments, met national guidelines 53.4 percent of the time. And care for acute conditions, such as urinary tract infections or severe fevers, met guidelines 67.6 percent of the time.
Some conditions fared better--children with colds or the flu received the correct care 92 percent of the time. Adolescents, however, received appropriate preventative care, like Chlamydia screenings and weight measurements, only 35 percent of the time.
The numbers are particularly striking, the researchers say, because all of the children in the study had some kind of health insurance -- 82 percent had private insurance -- and mostly came from middle and upper-middle class families.
Part of the problem may revolve around the health insurance reimbursement system, which pays doctors for the number of patients they see, not the results that they get, study co-author Elizabeth McGlynn, associate director of RAND Health, told ABCNews. So doctors may have only 10 minutes to spend with a patient, when doing a full physical would require 40 minutes.
"We have to take a very serious look at how we're paying physicians and hospitals," McGlynn said.
The study was conducted by researchers at the Seattle Children's Hospital, the University of California-Los Angeles and the RAND Corp., and was funded by the California HealthCare Foundation, the Robert Wood Johnson Foundation and the Centers for Medicare and Medicaid Services.