King Bio has issued a voluntary recall of dozens of medications for infants and young children after possible microbial contamination.
The medicines are used to treat ailments like bed wetting, chicken pox and colic.
The company said a small percent of the products sold between August 2017 and April 2018 have tested positive for microbial contamination.
Use of products with microbial contamination could "potentially result in increased infections that may require medical intervention and could result in infections that could be life-threatening to certain individuals," the FDA said.
However, King Bio has not received reports of injury or illness.
Consumers who have purchased the recalled items should stop using them and contact King Bio at firstname.lastname@example.org or call King Bio at 866-298-2740.