FDA Tightens Grip, Hyland’s Forced to Issue Nationwide Recall

FDA Tightens Grip, Hyland’s Forced to Issue Nationwide Recall

Hyland’s has been under extreme scrutiny from the Food and Drug Administration over the past few months. Now, the grip tightens, and Hyland’s has been forced to do a nationwide recall on all teething tablets.

Multiple teething tablets, including the Hyland’s Baby Teething Tablets and Hyland’s Baby Nighttime Teething Tablets, are in the recall.

Per the FDA, belladonna alkaloids in the tablets appear in multiple formulations, which are a serious health hazard to children.

Who is Hyland?

Hyland’s is one of the leading makers of homeopathic medications and products. However, they have been under investigation by the Food and Drug Administration for the past year, issuing multiple recalls.

The FDA has more than 400 cases of illnesses, including fever, seizures, and vomiting. Also, ten deaths have been linked to the use of these homeopathic teething tablets. In January 2017, the FDA confirmed that there were inconsistent levels of belladonna, including some with fatal levels of a highly toxic substance. Poisoning can be lethal.

Hyland’s refuses to take responsibility or acknowledge any dangers posed by their products. In public statements, they have lashed out against the FDA, and have not offered any concern about the affected infants or their grieving family members. Also, they have accused the FDA of creating a negative image for their company.

Today, Hyland’s still stands by their product, stating it is safe and that no official action is necessary. However, the FDA has now tightened restrictions on the manufacturer. They have issued a strongly worded letter stating that Hyland’s products represent a health hazard. Therefore, the FDA felt it was necessary to issue a full recall.

The same letter noted citations and violations at the facility where the teething tablets are produced. In a September 2016 inspection, they found that inconsistent levels of belladonna were present, and that there was no control over the toxic chemicals going into the company’s drugs.

Hyland’s still states, despite the violations, that they are excellent at quality control and that the FDA is creating consumer confusion.

The FDA does not recognize homeopathic medicine as a legitimate treatment. Therefore, proper measurement and batch accuracy are necessary to avoid injuries as seen in the Hyland’s case. Hyland’s added belladonna, but they were supposed to ensure small, consistent quantities were used. FDA reports show that Hyland’s failed to do so, and some tablets had toxic levels of belladonna present.

Last year, Standard Homeopathic Company ceased production of their teething tablets, but this recall is designed to ensure all remaining products are removed from the shelves. Anyone that owns Hyland’s teething tablet products are encouraged to discard them immediately.

Furthermore, the FDA warns parents that teething tablets are not necessary for small children. Instead, a gum massage, cold teething ring, or wash cloth is the safest way to soothe teething pain.

Comments

comments

COMMENTS