Teething Tablet Recall

Teething Tablet Recall
Homeopathic teething tablets and gels may be linked to hundreds of injuries and numerous deaths, prompting a warning from federal health regulators. While the U.S. Food & Drug Administration (FDA) has not issued a teething tablet recall, CVS has decided to pull a number of these products from its store shelves. The fallout from the FDA warning has also prompted Hyland’s to stop U.S. distribution of its homeopathic teething medicines.

Teething Tablet Lawsuit Reviews

Bernstein Liebhard LLP is offering free legal reviews to families whose children allegedly suffered serious adverse events due to the use of homeopathic teething remedies marketed by Hyland’s, Baby Orajel Naturals and others. To learn more, please contact our office today by calling (888) 994-5118.

Teething Tablets Linked to Injuries, Deaths

In September 2016, the FDA warned consumers to avoid giving infants and children homeopathic teething medications, after the products were implicated in seizures and other adverse events. By mid-October, various media outlets reported that more than 400 injuries and 10 deaths were possibly linked to these products.

The FDA had yet to conclude that any direct link between the medications and the deaths existed, and it did not announce a teething pill recall. However, the agency advised parents and caregivers to stop using the products, and to seek medical help if their children experienced any of the following symptoms after ingesting the medicines:

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

“Homeopathic teething tablets and gels have not been evaluated or approved by the FDA for safety or efficacy,” the FDA sated in its September 30th alert. “The agency is also not aware of any proven health benefit of the products, which are labeled to relieve teething symptoms in children.”

U.S. Teething Tablet Warning Reverberates in Ireland

On October 17, 2016, the Irish Republic’s Health Products Regulatory Authority (HPRA) warned that certain teething remedies manufactured in the U.S. could cause infants and children to suffer serious complications, and strongly advised parents to avoid using these products. The Authority acted in response to the FDA warning issued just weeks earlier in the U.S. Though none of the products referenced by the HPRA are licensed or sold in Ireland, they can be purchased over the internet. The Irish alert did not apply to homeopathic teething pills and gels sold in that country by Nelsons. Read More

Industry Response

Though the FDA did not go so far as to issue a teething tablet recall for any homeopathic medications, CVS did decide to remove such products from its store shelves. Teething remedies affected by the CVS action 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

Hyland’s announced that it would stop selling its homeopathic teething remedies in the U.S., due to confusion among parents and limited access to the medicines created by the FDA’s warning.

Incidentally, Hyland’s did announce a teething pill recall in 2010, after its products were linked to a number of adverse event reports consistent with belladonna toxicity. Belladonna is an ingredient in many homeopathic teething remedies, and is poisonous in large doses. An FDA investigation determined that the company’s teething medications contained inconsistent amounts of belladonna. Hyland’s did eventually reformulate the products and return them to store shelves.

Homeopathic Teething Tablets, Ear Relief Meds Recalled for Belladonna

In November 2016, Raritan Pharmaceuticals announced a recall for the following homeopathic remedies:

  • 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

The recall was characterized as precautionary, as testing had indicated that the products contained inconsistent amounts of belladonna. Ingesting large amounts of this ingredient can prove toxic. However, no injuries have been linked to the recalled medications. Read More

In April of the following year, the Standard Homeopathic Company announced a recalled all lots of:

  • Hyland’s Baby Teething Tablets
  • Hyland’s Baby Nighttime Teething Tablets.

Just four months earlier, the FDA confirmed that the Hyland’s products contained inconsistent amount of belladonna. However, Standard Homeopathic did not agree to a recall the teething tablets at that time.

Parents and caregivers should not administer these medications to their children. For more information, contact Standard Homeopathic at 1-800-991-3376 (Monday-Friday 6 a.m. to 4 p.m. Pacific Time).  Read More

Learn More about Filing a Teething Tablet Lawsuit

Families whose children were allegedly harmed by homeopathic teething pills and gels may be entitled to compensation. To discuss filing a teething tablet lawsuit with a member of our legal staff, please call Bernstein Liebhard LLP at (888) 994-5118.

  1. FDA (2016) “FDA warns against the use of homeopathic teething tablets and gels” http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm523468.htm
  2. Bloomberg (2016) “Giving Teething Babies Homeopathic Remedies Could Kill Them” http://www.bloomberg.com/news/articles/2016-10-12/giving-teething-babies-homeopathic-remedies-could-kill-them
  3. CVS (2016) https://www.cvshealth.com/newsroom/press-releases/cvs-pharmacy-announces-voluntary-withdrawal-homeopathic-teething-products
  4. Hyland’s (2016) “A Letter From Hyland’s” http://www.hylands.com/hylands-discontinues-teething-tablets-and-gels
  5. FDA (2010) “Hyland’s Teething Tablets may pose a risk to children” http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm230761.htm
Last Modified: May 2, 2017

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