Children’s Homeopathic Ear and Teething Relief Products Recalled Due to Belladonna

Recently, the FDA posted a voluntary recall from Raritan Pharmaceuticals of homeopathic children’s remedies containing belladonna extract. Belladonna, also known as “deadly nightshade,” is a plant traditionally used in herbal remedies that can be poisonous, and even fatal, if consumed in a sufficiently large dose. The recall affects the following Raritan products: Kids Relief Homeopathic Ear Relief Oral Liquid, CVS Homeopathic Kids’ Ear Relief Liquid, and CVS Homeopathic Infants’ Teething Tablet.

According to the release, the products are being recalled because FDA testing recovered levels of belladonna extract “varying . . . from what is declared on the label.” The FDA has warned that inconsistent labeling of belladonna content can lead to children being exposed to dangerous doses.

In September, the FDA warned consumers that “homeopathic teething tablets and gels may pose a risk to infants and children.” This warning comes as the FDA has received numerous reports of serious symptoms such as seizures and breathing difficulty in children given these products and in investigating ten infant deaths that may be related to the products. The FDA is recommending “that consumers stop using these products and dispose of any in their possession.”

This is not the first FDA warning relating to homeopathic teething products: in 2010, the FDA warned that Hyland’s Teething Tablets may pose a risk to children after finding that the tablets “contain inconsistent amounts of belladonna” and receiving “reports of serious adverse events in children taking this product that are consistent with belladonna toxicity.” Hyland’s has not recalled the product, but retailers such as CVS has pulled them from their shelves.

If you or someone you know has been injured by a recalled product, contact an attorney at Abraham, Watkins, Nichols, Agosto, Aziz & Stogner by calling (713) 222-7211 or toll free at 713-222-7211.