Hyland's recalls popular teething tablets after FDA investigation

Standard Homeopathic Company is recalling its popular Hyland's teething tablets, the U.S. Food and Drug Administration announced.

The FDA last fall began investigating the products after receiving reports of deaths and seizures possibly connected to the tablets. At the time, Standard Homeopathic Company stopped making and shipping the products to retailers, but did not require stores to take them off the shelves and in statements told parents the products were safe to use.

The FDA investigation found some of the tablets contained inconsistent amounts of belladonna, a toxic substance, "sometimes far exceeding the amount claimed on the label," according to a news release from the federal agency. On April 10, the FDA formally requested the company recall the products. Three days later, the company complied.

The recall applies specifically to Hyland's Baby Teething Tablets and Hyland's Baby Nighttime Teething Tablets.

The FDA reported receiving more than 400 reports of adverse effects, including seizures, shortness of breath and tremors within the past six years.

MORE: Homeopathic teething tablets contain toxic substance, FDA confirms

"We are also aware of reports of 10 deaths during that time period that reference homeopathic teething products, though the relationship of these deaths to the homeopathic teething products has not yet been determined and is currently under review," the FDA said in an emailed statement to The Arizona Republic last fall. Friday, an FDA official said they still believe the 10 deaths were associated with homeopathic teething products, but did not have details on the investigation.

Company spokeswoman Mary Borneman in a news release said the recall will assure any products still on store shelves are removed.

"We are committed to maintaining and earning the trust consumers have placed in Standard Homeopathic Company," she said in the statement.

Parents who have the products should throw away any remaining teething tablets, Borneman said. Anyone with questions regarding the recall can call Standard Homeopathic Company at 800-991-3376.

Some stores already pulled teething products

The FDA recommends parents not give infants or children any product that contains belladonna.

Hyland's, Orajel and CVS are among the companies that produce and distribute homeopathic teething gels and tablets. After the FDA's warning, CVS voluntarily removed all homeopathic teething products from its stores. Homeopathic medicines include ingredients from natural sources, such as plants or minerals. Belladonna is a homeopathic ingredient.

Right up until issuing the recall Thurdsay, the company stood by its product.

"Hyland's Baby Teething Tablets have safely treated the pain associated with teething for more than 85 years. There is NO scientific link between homeopathically-prepared belladonna, or Hyland's Baby Teething Tablets, and seizures," its website stated on the day the recall was announced.

The website was later updated to remove this and notify customers of the recall. They maintain on the site that "we are confident the product is safe."

How to report adverse effects

Consumers should seek medical treatment if their child experiences seizures, breathing difficulties, lethargy, sleepiness, muscle weakness, constipation, skin flushing, difficulty urinating and agitation after using these products, the FDA said.

Anyone whose child has had adverse effects is asked to report them to the FDA's MedWatch Adverse Event Reporting program.