In a news release Monday, the FDA said the drops come with a syringe that could make it confusing for parents to give their children the proper dose, leading to overdose.
According to the FDA, the directions on the bottle and labeling allow for safe dosing for children between the ages of 2 and 3 who weigh between 24 and 35 pounds.
However, the oral dosing syringe is not marked to accurately measure doses less than 1.6 mL, which doctors could prescribe for children younger than 2 years who weigh less than 24 pounds.
As a result, Perrigo Co. is voluntarily recalling:
Cherry Flavor Infant Pain Reliever, 160 mg acetaminophen (0.5 ounces and 1.0 ounces)
Grape Flavor Infant Pain Reliever, 160 mg acetaminophen (0.5 ounces and 1.0 ounce)
Cherry Flavor Cough and Cold Infant Drops (0.5 ounces)
Cherry Flavor Decongestant and Cough Infant Drops (0.5 ounces)
