Hyland's Baby Teething Tablets Recalled Due to Mislabeling, Concerns over Belladonna
The FDA believes that belladonna represents a serious health hazard to children and that its effects are unpredictable, with no known safe dose
Standard Homeopathic Company is recalling all lots of Hyland's Baby Teething Tablets and Hyland's Baby Nighttime Teething Tablets sold in retail stores.
According to the U.S. Food & Drug Administration (FDA), the medicines have been found to contain inconsistent amounts of belladonna alkaloids that may differ from the calculated amount on the products' labels.
The FDA believes that belladonna represents a serious health hazard to children and that its effects are unpredictable. "There is no known safe dose or toxic dose of belladonna in children because of the many factors that affect it," the FDA said in a statement to the company.
Hyland's Baby Teething Tablets and Hyland's Baby Nighttime Teething Tablets are intended to provide temporary relief of teething symptoms in children. The recall includes all products that retailers have in stock. The FDA says that Standard Homeopathic Company stopped making and shipping the medicines nationwide in October 2016. This recall ensures the removal of any possible remaining products that may be on store shelves. No other Standard Homeopathic Company/Hyland's products are affected by this recall.
"We initiated this recall even after discontinuing production last fall because it is appropriate to do what our regulating agency has formally requested," said J.P. Borneman, chairman and CEO of Standard Homeopathic Company. "We are committed to maintaining and earning the trust consumers have placed in Standard Homeopathic Company. We have worked for 114 years to build relationships with our consumers. We intend to preserve that tradition of trust."
Standard Homeopathic Company is notifying its distributors and retailers by mail and is arranging for the return of all recalled products. Consumers in possession of any Hyland's Baby Teething Tablets or Hyland's Baby Nighttime Teething Tablets should discard the products immediately.
Consumers with questions regarding this recall can contact Standard Homeopathic Company by calling (800) 991-3376.
Consumers should contact their physician or healthcare provider if they believe they have experienced any adverse affects related to taking or using the recalled products.