Teething Tablets Recall

Published on December 2, 2016 by Sandy Liebhard

Text-Size:A A A+

Was your child harmed by a medication included in a teething tablets recall? A number of companies have recently issued recalls for homeopathic teething tablets and gels, following reports linking such products to serious adverse events.

Teething Tablets Attorneys

The attorneys at Bernstein Liebhard LLP are investigating legal claims related to homeopathic teething remedies. If your child suffered serious complications following treatment with a recalled teething product, please call to learn more about your available legal options.

FDA Teething Tablets Warning

In September 2016, the U.S. Food & Drug Administration (FDA) warned that homeopathic teething tablets may have been associated with 10 infant deaths, as well as 400 adverse events. These incidents included:

  • Seizures
  • Difficulty breathing
  • Lethargy
  • Excessive sleepiness
  • Muscle weakness
  • Skin flushing
  • Constipation
  • Difficulty urinating
  • Agitation

While the FDA has yet to conclude that homeopathic remedies caused any of the incidents, the regulator warned that the products should not be used to relieve teething pain in children.

“Teething can be managed without prescription or over-the-counter remedies,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “We recommend parents and caregivers not give homeopathic teething tablets and gels to children and seek advice from their health care professional for safe alternatives.”

The FDA’s alert prompted CVS to pull homeopathic teething tablets and gels from its store shelves. Affected products included:

  • Baby Orajel Naturals Gel for Teething Pain, .33 oz
  • Baby Orajel Naturals Gel for Teething Pain Nighttime Formula, .33 oz
  • Baby Orajel Naturals Tablets for Teething Pain, 125 Count
  • CVS Homeopathic Infant’s Teething Tablet, 135 Count
  • CVS Homeopathic Infants’ Teething Liquid, .85 oz
  • Hyland’s Baby Nighttime Teething Tablets, 135 Count
  • Hyland’s Baby Teething Gel, .5 oz
  • Hyland’s Baby Teething Tablets, 13 Count
  • Hyland’s Baby Teething Tablets, 135 Count
  • Hyland’s Teething Gel, .33 oz

Walgreen’s also took similar action. Hyland’s announced that it would no longer sell its homeopathic teething tablets in the U.S.

Teething Remedies Recalled for Belladonna

Hyland’s Teething Tablets were recalled in October 2010, following reports of serious adverse events in children taking the medications. Like many homeopathic teething products, the tablets were made with small amounts of belladonna, which can be toxic in large amounts. Laboratory analysis conducted by the FDA indicated that the Hyland’s tablets contained inconsistent amounts of the ingredient, while the adverse event reports received by the agency were consistent with belladonna toxicity.

In November 2016, a precautionary teething tablets recall was announced by Raritan Pharmaceuticals for the following homeopathic products:

  • CVS Homeopathic Infants’ Teething Tablet 135 tablets, UPC: 050428424162, Lots: 41116 and 43436
  • Kids Relief Homeopathic Ear Relief Oral Liquid 0.85 fl. oz., UPC: 778159090639, Lot: 35254
  • CVS Homeopathic Kids’ Ear Relief Liquid 0.85 fl. oz., UPC: 050428441633, Lot: 33149

Testing had also indicated that the Raritan medications contained varying amounts of belladonna. However, no injuries have been reported in relation to those products.

Obtain a Free Case Review

Children harmed by homeopathic medications included in a teething tablets recall may be entitled to compensation. To learn more, please call to obtain a free, no-obligation review of your case.

Web Analytics