Homeopathic teething tablets and gels are sold in retail stores and online in the US.
Consumers should seek medical care immediately if their child experiences seizures, difficulty breathing, lethargy, excessive sleepiness, muscle weakness, skin flushing, constipation, difficulty urinating or agitation after using homeopathic teething tablets or gels.
"Teething can be managed without prescription or over-the-counter remedies," said Janet Woodcock, director of the FDA's Centre for Drug Evaluation and Research.
"We recommend parents and caregivers not give homeopathic teething tablets and gels to children and seek advice from their health care professional for safe alternatives," said Ms Woodcock.
The FDA is analysing adverse events reported to the agency regarding homeopathic teething tablets and gels, including seizures in infants and children who were given these products, since a 2010 safety alert about homeopathic teething tablets.
Homeopathic teething tablets and gels have not been evaluated or approved by the FDA for safety or efficacy.
The agency is also not aware of any proven health benefit of the products, which are labelled to relieve teething symptoms in children.
The FDA encourages health care professionals and consumers to report adverse events or quality problems experienced with the use of homeopathic teething tablets or gels.