Hyland’s Baby Teething Tablets and Hyland’s Baby Nightime Teething Tablets have been voluntarily recalled by the manufacturer. Standard Homeopathic Company, a Los Angeles-based company received the FDA’s formal recall request and agreed to conduct a recall on April 10th.
The FDA found that homeopathic teething tablets contain belladonna and pose an unnecessary risk to infants and children using the products. The FDA urged customers to discontinue the use of the products. On January 27, 2017, the FDA announced its laboratory analysis had found that an inconsistent amount of belladonna, a toxic substance was present in the products sometimes far exceeding the amount claimed on the label.
The FDA received and analyzed adverse events reported regarding the use of the homeopathic teething tablets and gels. These reactions included seizures in infants and children who were given these products. The FDA investigated the reports including testing of product samples. Homeopathic teething tablets and gels have not been evaluated or approved by the FDA for safety or for efficacy.
“Teething can be managed without a prescription or over-the-counter remedies,” said Janet Woodcock, M.D., director of the FDA’s Center 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.”
Both distributors and retailers have been alerted by mail and is in the process of arranging for the return of all of the recalled products. “The agency is also not aware of any proven health benefit of the products, which are labeled to relieve teething symptoms in children,” FDA officials said.
The lab results finding inconsistent amounts of belladonna led the FDA officials to contact the Standard Homeopathic Company on January 25, 2017, in order to protect consumers from the possible adverse reactions.
Consumers who have products which are being recalled should contact the company. Consumers with questions regarding this recall can contact Standard Homeopathic Company by calling 1-800-991-3376 (Monday-Friday 6 a.m. to 4 p.m. Pacific Time). Consumers should contact their physician or healthcare provider if they believe they have experienced any problems that may be related to taking or using this drug product.
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- Teething-Tablets: Photo by The U.S. Food and Drug Administration