The FDA warned health care providers and consumers today about the potential for serious adverse events with Hyland’s Teething Tablets, an over-the-counter homeopathic product intended to help relieve pain from teething symptoms.

The agency issued a consumer safety alert after receiving reports of toxicity in children who were given the product. An FDA laboratory analysis revealed that the tablets contain inconsistent amounts of belladonna – a plant long used as an anesthetic in traditional and alternative medicine that can be harmful in large amounts.

Consumers should discontinue using Hyland’s Teething Tablets and contact their health care provider if their child has recently used the product and experienced the following symptoms: seizures, difficulty breathing, lethargy, excessive sleepiness, muscle weakness, flushed skin, constipation, difficulty urinating or agitation.

The manufacturer, Standard Homeopathic Company, has issued a voluntary recall while the FDA continues to inspect manufacturing facilities.

The FDA advises consumers and health care providers to report product-related adverse events to MedWatch.