The maker of Hyland’s Baby Teething Tablets and Hyland’s Baby Nighttime Teething Tablets is recalling the products at the consumer level. A recall on the U.S. Food and Drug Administration’s (FDA) website said the tablets “have been found to contain inconsistent amounts of belladonna alkaloids that may differ from the calculated amount on the products’ labels.” Belladonna, a perennial herbaceous plant, is a “toxic substance,” according to the FDA.

“FDA believes that belladonna represents a serious health hazard to children and that the effects of belladonna are unpredictable,” a statement reads. “The agency has stated to the company, ‘There is no known safe dose or toxic dose of belladonna in children because of the many factors that affect it.'” The recall comes just six months after the FDA issued a warning urging consumers to stop using homeopathic teething tablets and gels, as they may pose a risk to infants and children.

Hyland’s stopped making the medicines in October 2016. The latest recall covers all Hyland’s products that may have still been on store shelves. The tablets were used to provide temporary relief of teething symptoms. Children who experience seizures, difficulty breathing, lethargy, excessive sleepiness, muscle weakness, skin flushing, constipation, difficulty urinating, or agitation after using homeopathic teething tablets or gels should seek medical care immediately. For more information, contact the Standard Homeopathic Company by calling 800-991-3376 Monday through Friday. Consumers should contact their health care provider if they believe they have experienced any problems that may be related to taking or using this drug product.

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