A recall has been issued for all Hyland’s Homeopathic Teething Tablets because they contain toxic belladonna (deadly nightshade). At least 10 baby deaths and over 400 reports of seizures and side effects were reported since the first recall in 2010.
Need a Texas Hyland’s Lawyer? Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged. If your baby had belladonna poisoning, you should contact our lawyers immediately. You may be entitled to compensation by filing a lawsuit.
Hyland’s Homeopathic Teething Tablet Recall
April 2017 — Standard Homeopathic Company recalled all Hyland’s Baby Teething Tablets and Nighttime Teething Tablets because they may contain dangerous levels of extremely poisonous toxic belladonna (deadly nightshade).
Tablets Recalled in 2010 After Seizures Reported
FDA testing found widely inconsistent levels of toxic belladonna in Hyland’s Homeopathic Teething Tablets in 2010. The agency also reported babies who had seizures and symptoms of poisoning. Hyland’s issued a recall in October 2010, but did not remove belladonna, and told customers the products were safe. They returned to stores in 3 months.
10 Deaths and 400 Reports of Belladonna Poisoning
Ten baby deaths and over 400 illnesses were reported to the FDA by parents who gave their infants Hyland’s Homeopathic Teething Tablets between October 2010 and October 2016 — six years after the first recall. Some of the reports were absolutely heart-wrenching:
“My daughter had a seizure, lost consciousness, and stopped breathing about 30 minutes after I gave her three Hyland’s Teething Tablets… She had to receive mouth-to-mouth CPR to resume breathing and was brought to the hospital.”
FDA Confirms Elevated Levels of Belladonna
In September 2016, the FDA warned the public that Hyland’s Teething Tablets contained high levels of belladonna, and then confirmed the risk in January 2017. Hyland’s refused to issue a recall, did not express any concern for babies who died, and criticized the FDA for creating “confusion” for its customers.
List of Recalled Teething Tablets & Gels
After the FDA warning in September 2016, CVS stores stopped selling the following homeopathic teething tables and gels:
- 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
In November 2016, Raritan Pharmaceuticals recalled three belladonna-containing homeopathic products, two of which were marketed by CVS:
- CVS Homeopathic Infants’ Teething Tablet, 135 tablets
- Kids Relief Homeopathic Ear Relief Oral Liquid 0.85 fl. oz.
- CVS Homeopathic Kids’ Ear Relief Liquid 0.85 fl. oz.
What’s the problem?
Hyland’s stopped distributing teething tablets in October 2016, but they could still be found on store shelves, online, and in people’s medicine cabinets. The FDA urged Hyland’s to recall the rest of the products, but the company refused, insisting the products were safe.
Fundamental Lack of Control Over Toxic Ingredients
On April 7, 2017, the FDA sent Hyland’s a Letter (PDF) demanding a recall because the products “represent a serious health hazard.” As such, “FDA action is necessary to protect public health and welfare.”
The FDA cited a number of violations discovered at Hyland’s manufacturing facility in Los Angeles, California, including specific test results showing inconsistent levels of toxic belladonna. According to the FDA:
“This variability in belladonna alkaloid concentrations indicates a fundamental lack of control over the content of toxic chemicals in your drug.”
Unpredictable and Unnecessary Risk to Babies
Belladonna is extremely poisonous even at low levels. Small amounts of belladonna will poison a baby, especially a baby who is given a lot of tablets as they go through teething for months or years.
It is also unpredictable how a baby’s body will respond to belladonna because their kidneys and liver are still developing. For example, the baby may not have enough liver enzymes to break down belladonna or enough kidney function to remove belladonna from their body.
This could lead to belladonna toxicity as the poisons accumulate in their body. According to the FDA:
“The ability of infants to metabolize and eliminate belladonna alkaloids is impaired due to the complex development of hepatic enzymes and non-linear maturation of renal function.”
Symptoms of Belladonna Poisoning
Belladonna contains chemicals that can block functions of the body’s nervous system, including nerves that control salivation, sweating, pupil size, urination, digestive functions, and others. The symptoms of belladonna toxicity may include:
- Trouble breathing
- Excessive sleepiness
- Muscle weakness
- Fast heart-rate
- Hot body temperature
- Dry mouth
- Skin flushing
- Less urination
- Agitation or irritability
- Dilated pupils
Need a Hyland’s Recall Lawyer in Texas?
Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged.
Collen’s amazing success in the courtroom and well known dedication to his clients has earned him the recognition of his peers as one of The Top Trial Lawyers in Texas.”
The Clark Firm has assembled a team of trial lawyers with more than 100 years experience, participation in over 600 jury trials and $260 million in verdicts and/or settlements. Please use the form below to contact our Texas Hyland’s recall lawyers for a free lawsuit review.