Recall Alert: Popular Teething Products

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The FDA has announced an immediate recall for homeopathic teething tablets and gels after discovering that the company has been seriously mislabeling one dangerous ingredient in the products.

Last year, the FDA began warning parents against using homeopathic teething tablets and gels and one popular brand announced in October that they would stop distributing the products in the US.

This, however, means that some products are still available for purchase in stores, even though the official distribution by the company may have ended. Now, the FDA has announced that they are recalling all lots of Hyland’s Baby Teething Tablets and Hyland’s Baby Nighttime Teething Tablets sold in retail stores to the consumer level.

The teething products were linked to 10 children’s deaths last year and now, the FDA has had enough.

The official recall notice from the FDA explains that the recall is going down because the U.S. Food & Drug Administration (FDA) “has 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.”

Belladonna may be a “natural” product, that does not necessarily mean it is safe. The recall explains that the FDA believes that belladonna is, in fact, a “serious health hazard to children” and that “the effects of belladonna are unpredictable.”

The FDA also issued a statement to Hyland Baby saying: “There is no known safe dose or toxic dose of belladonna in children because of the many factors that affect it.”

The Hyland’s website now also includes a big, red warning in bold that this product is no longer being distributed in the United States, despite the happy description which follows: “Something sounds good – even to your fussy, teething baby. It’s the shake-shake of a Hyland’s Baby Teething Tablets bottle. These tablets have rocked the charts by being the #1 infant oral pain reliever in America!♩ They make nights bearable, days livable, and truly make the teething years way more groovy. Easy to use, no mess, no fuss – Hyland’s Baby Teething Tablets have perfect timing, right there whenever you need them.”

As per protocol, the FDA notes that the company will be contacting distributors to return the product.

Parents – if you bought these tablets, please discard the product.

If you have questions regarding the recall, the FDA encourages you to contact Standard Homeopathic Company by calling 1-800-991-3376 (Monday-Friday 6 a.m. to 4 p.m. Pacific Time). If you think your baby has had an adverse reaction or problem because of the teething products, you should contact your doctor and if he or she agrees, fill out the relevant documentation about an adverse reporting event.