Non-prescription drugs used to combat cold and cough symptoms in children under the age 2 can lead to fatalities, and this is why a massive, nationwide recall has been issued.

Large corporations like Johnson&Johnson, Wyeth, Novartis or Prestige Brands Holdings are recalling their over-the-counter medications for infants, the Consumer Healthcare Products Association reported on Thursday. The reason is FDA’s recent study that showed 54 deaths have been registered between 1969 and 2004 due to overdose of cold and cough medicines.

CVS Pharmacy, the retail unit of CVS Caremark Corp, Stop & Shop Supermarket Co LLC and Giant Food LLC will also issue recalls for their respective products.

Parents should not worry too much though: the medicines are very effective when used properly, according to doctor’s prescription.

FDA reviewers have suggested that over-the-counter cough and cold medicines that contain decongestants and antihistamines be put under new restrictions, warning parents what is and what is not recommended for very young children..

The FDA panel recommended that the medicines’ labels "should include prominent language to describe the risk of overdose in children." They also recommended dropping the statement on many over-the-counter remedies urging parents to "consult a physician" about use of decongestants in children under 2 and antihistamines in children under 6.

However, a final decision is not to be expected sooner than October 18, when advisers outside the FDA will provide their feedback on the matter.

"At this point, the studies that have been done show no benefit and we do have reported, although rare, bad outcomes," said Dr. Richard Gorman, chair of the American Pediatrics section on clinical pharmacological and therapeutic studies, and a pediatrician in Baltimore.

"There are no good studies that provide any information about appropriate dosing if they did work," said Dr. Steven Czinn, chair of the department of pediatrics at the University of Maryland School of Medicine and a signer of the petition.

"In the 21st century, it is unacceptable to be marketing medication to infants and children that may not work," Czinn said.