The maker of Hyland's teething tablets has issued a recall for any remaining packages at the urging of US regulators, who say the medicine has inconsistent levels of a herb that can be poisonous.
Under the recall announced Thursday, the company will notify distributors and retailers and arrange for the return of all the products.
The recall covers all Hylands Baby Teething Tablets and Hylands Baby Nighttime Teething Tablets, products meant to relieve discomfort from emerging teeth.
A nationwide recall is underway for baby teething tablets that the FDA says are unsafe.
The FDA told Standard Homeopathic Company, makers of the Hyland Teething Tablets, that, "There is no known safe dose or toxic dose of belladonna in children because of the many factors that affect it". However, the agency found varying levels of belladonna when it tested Hyland's teething tablets, including some that far exceeded what was listed on the labels.
The company halted the production and shipment of the tablets in October, but they may be stocked in stores and in some consumer's cabinets. This recall ensures the removal of any possible remaining products that may be on store shelves.
"We are committed to maintaining and earning the trust consumers have placed in Standard Homeopathic Company", said CEO J.P. Borneman in a statement. Anyone with questions should call calling 1-800-991-3376.
Last September, the FDA issued a news release cautioning that homeopathic teething tablets and gels may be harmful to babies and children with a strong recommendation to not use them.
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.