The Standard Homeopathic Company recalled baby teething tablets due to mislabeling.
Hyland's Baby Teething Tablets and Hyland's Baby Nighttime Teething Tablets were sold in retail stores to the consumer level.
The recall includes all products that retailers may have had in stock.
The 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.
Standard Homeopathic Company is notifying its distributors and retailers by mail and is arranging for the return of all recalled products. Consumers who have products which are being recalled should discard the product.
The U.S. Food and Drug Administration concluded that the medicines have been found to contain inconsistent amounts of belladonna alkaloids that may differ from the calculated amount on the products' labels.
FDA believes that belladonna represents a serious health hazard to children and that the effects are unpredictable.
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 teething tablets were used to provide temporary relief of teething symptoms in children.
Consumers with questions about the recall can contact Standard Homeopathic Company by calling 1-800-991-3376 (Monday through 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 the product.