Hyland’s Teething Tablets Recall Lawsuit

Free Confidential Teething Tablet Lawsuit Evaluation: If your child or other loved one was injured, you should contact our law firm immediately. You may be entitled to compensation by filing a teething tablet lawsuit and our law firm can help.

Update: FDA Cites Teething Tablet Manufacturer for GMP Violations

An FDA warning letter sent recently to Raritan Pharmaceuticals — the New Jersey CMO that manufactured Hyland’s Homeopathic Teething Tablets — cited the company for numerous violations ranging from misbranding to inadequate quality testing and procedures.

The agency slammed Raritan for failing to test the quality of its ingredients and not having manufacturing processes in place that would ensure consistent ingredient levels.

Timeline of Key Events in the Hyland’s Teething Tablet Case

• 2010: Initial safety concerns arise, with reports of adverse reactions in infants.
• 2016: FDA launches a formal investigation, discovering a link between the tablets and serious health risks, including seizures.
• 2017: A recall announcement is made, urging parents to stop using the product and return it following immediately confirmed safety issues.
• Current Status of Litigation: Lawsuits are ongoing, with affected families pursuing compensation for health impacts, alleging negligence and failure to warn consumers.

Hyland’s Teething Tablets Recall – Serious Safety Risk of Harm to Children

The FDA warns parents that Hyland’s Homeopathic Teething Products are being recalled because they may harm children. The tablets are manufactured to contain a small amount of belladonna, a substance that can cause serious harm at larger doses.

For such homeopathic treatments, the amount of belladonna must be carefully controlled. FDA noted that the tablets contain inconsistent levels of belladonna.

FDA warns of serious adverse events in children taking this product that are consistent with belladonna poisoning. The FDA has also received reports of children who consumed more tablets than recommended because the containers do not have child-resistant caps.

FDA advises consumers to consult their health care professional if their child experiences symptoms such as:

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

If you have noticed these symptoms in your child after using homeopathic teething medications, you should seek medical care immediately. Filing a Hyland’s teething tablet lawsuit can help you recover lost wages and medical expenses that were the result of belladonna toxicity poisoning from teething products.

What is Belladonna Poisoning?

Belladonna, commonly known as nightshade, is a toxic plant with a history of medicinal use. While it has been utilized for its therapeutic properties, improper ingestion can lead to serious health complications. Understanding the symptoms and potential risks associated with belladonna poisoning is essential for timely medical intervention.

Specific Symptoms of Belladonna Poisoning

Belladonna poisoning can present a variety of symptoms, which may vary based on the amount ingested and the individual’s sensitivity.

Common symptoms include:

• Dilated Pupils: A hallmark sign of belladonna poisoning, often accompanied by light sensitivity.
• Blurred Vision: Difficulty focusing due to paralysis of eye muscles.
• Increased Heart Rate (Tachycardia): The body’s response to the toxic effects can lead to a rapid heartbeat.
• Dry Mouth and Throat: Reduced salivation leads to discomfort and difficulty swallowing.
• Difficulty Swallowing: Throat muscle paralysis can hinder swallowing.
• Confusion and Hallucinations: Neurological effects, including delirium, can cause altered mental status.
• Severe Agitation or Delirium: Some individuals may experience extreme agitation or confusion.
• Nausea and Vomiting: Gastrointestinal distress may follow ingestion.

How Does Belladonna Lead to Teething Tablet Overdose and Toxicity?

Hyland’s homeopathic teething tablets and gels were supposed to contain only very tiny amounts of belladonna. However, an FDA laboratory study revealed that the teething products contained a varying amount of belladonna. However, belladonna is a poisonous substance.

As such, because of the inconsistent amounts in each dose, many parents unknowingly gave their children an overdose of belladonna while believing they were administering the proper dose.

The tiny amounts of poison may pose little risk to adults; however, this is not the case in children. Even low levels of belladonna in children can lead to muscle weakness, seizures and difficulty breathing. Belladonna contains several toxic ingredients, including atropine.

Using words like “natural,” Hyland could lull parents into a sense of comfort believing that they weren’t giving their children anything harmful in their teething products.

Atropine works by blocking a very common neurotransmitter in the parasympathetic nervous system. This part of the brain controls unconscious functions such as breathing, urinating, digesting, and heartbeat.

Naturally, when atropine is introduced into the body at high levels, the brain loses control of these functions, and it becomes deadly. In homeopathy, atropine treats redness and inflammation.

What Does the FDA Say About Belladonna Toxicity?

After a September 2016 inspection of the Standard Homeopathic Company, the FDA determined that the inconsistent levels of belladonna alkaloids in the company’s teething products were a serious health hazard. The company initially declined to recall its homeopathic teething products.

In a January 2017 phone call with FDA, company CEO Jay Borneman stated that he would not initiate a recall and believed “that the public is amply protected.” In April 2017, the FDA sent a letter requesting that Standard Homeopathic Company recall all of its Hyland’s Teething Tablets or gels.

Later that month, the FDA issued a Class I recall for all of Hyland’s homeopathic teething tablets and gels for teething babies. This is not the first time the FDA has issued a warning regarding homeopathic drugs.

In 2010, Hyland’s agreed to issue a teething tablet recall voluntarily. This recall came after experts tied homeopathic medication to adverse events, including seizures in infants and children.

After consultation with the FDA, the manufacturer of the product, Standard Homeopathic Company, issued the second 2017 recall of homeopathic medicine from the market.

What is the History of Hyland’s Homeopathic Teething Tablets?

Hyland’s homeopathic products have been around since 1903. Hyland’s tablets weren’t introduced to the U.S. market until 1945. For more than seven decades, millions of parents gave homeopathic medicine to their children for the proven health benefit of alleviating teething pain.

The FDA warned consumers in 2010, to toss their supply of Hyland’s teething tablets and gels. This alert found inconsistent amounts of belladonna in the company’s homeopathic medicine.

At the time, the FDA received numerous reports about serious adverse effects linked to homeopathic medications. The symptoms the children experienced were consistent with belladonna toxicity. Eventually, the FDA advised parents to stop using the products immediately.

Standard Homeopathic Company issued a voluntary recall in 2010 because of inconsistent levels of belladonna as well as packaging problems in their homeopathic drugs. The company remained (and continues to remain) adamant that its product was safe for use.

However, as part of the FDA’s investigation, the company revamped its production, packaging and testing protocols. The company claims it worked closely with the FDA throughout the process.

In a press release on the company website, President and Chief Pharmacist Mark Phillips said, “we initiated this voluntary recall to ensure our consumers know that their families’ safety and health are our top priorities. We are committed to maintaining and deserving the trust they have placed in Hyland’s. We have worked for 107 years to build relationships with our consumers. We intend to preserve that tradition of trust.”

Related article: Homeopathic Class Action Settlement

Teething Tablet Alternatives

For many parents, it’s difficult to see their child in pain. However, parents should always be mindful of the possible dangers the medication they administer to their children poses. The American Academy of Pediatrics offers the following alternatives for treating teething pain.

Rub your baby’s gums. Make sure you wash your hands first, but a clean finger or a moistened gauze pad to rub your baby’s gums is effective in relieving teething symptoms. The pressure eases or erases your baby’s discomfort.

Stick it in the Fridge. A cold washcloth, spoon or chilled teething ring can soothe your baby’s gums. Never give your baby a frozen teething ring; frozen rings are hard and can bruise your baby’s gums. Additionally, frozen temperatures can frostbite your baby’s lips or gums.

Eat hard foods. If your baby is eating solid foods, offer something hard, yet edible to gnaw on. A chilled and peeled cucumber or carrot can give your baby much-needed relief. However, it is important to keep a close eye on your baby. Any pieces that break off might pose a choking hazard.

Dab the drool. Excessive drooling is part of the teething process. Objects in the mouth, such as teething rings or fingers, produce saliva. Excessive saliva can lead to skin irritation. Keep a clean cloth handy to dry your baby’s chin.

Over-the-counter remedies. If your baby is especially cranky from teething, children’s Tylenol or Motrin might help. Talk to your child’s doctor about what over-the-counter is best for your child’s pain.

While teething is usually treatable at home, contact your doctor if your baby develops a fever or seems particularly uncomfortable. Further, you should always avoid over-the-counter medicines that contain OTC benzocaine teething products with belladonna.

Hyland’s Tablets Recalled in Australia

May 2, 2017 – Australia’s Therapeutic Goods Administration (TGA) has issued a recall for Hyland’s Teething Tablets or gels over concerns that inconsistent belladonna alkaloids may harm children.

The recall does not include Hyland’s baby teething gel; however, all Hyland’s baby teething products, including the gel and other medical devices, will no longer be sold in Australia.

CVS Teething Tablets, Children’s Ear Medicine Recalled for Inconsistent Belladonna

November 28, 2016 – Raritan Pharmaceuticals has issued a voluntary recall for homeopathic products containing belladonna, “a substance that can cause harm at larger doses.” Products affected by the recall include:

• 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

Hyland’s Teething Tablets Recalled Over Inconsistent Belladonna

April 14, 2017 – Standard Homeopathic Company is recalling all lots of Hyland’s Baby Teething Tablets and Hyland’s Baby Nighttime Teething Tablets over inconsistent amounts of belladonna. The company stopped manufacturing and distributing the medicines last October. This recall ensures the removal of any possible remaining products that may be on store shelves.

FDA Confirms Elevated Belladonna Levels in Teething Tablets

January 27, 2017 – An FDA investigation has revealed inconsistent amounts of belladonna — sometimes far exceeding the amount printed on the labeling — in homeopathic medicines. The agency warns that teething tablets pose an unnecessary risk to infants and children and recommends that consumers avoid the products [1].

FDA has completed testing of homeopathic teething tablets labeled as containing belladonna and other ingredients and marketed by CVS and Hyland’s Inc. Our testing found that the belladonna alkaloids (atropine and scopolamine) content and coffea cruda (caffeine) content is not uniform among the manufactured tablets. – US Food and Drug Adminstration

Baby Nighttime Teething Tablets Class Action Filed in New York

January 4, 2017 – A lawsuit has been filed in New York for consumers who purchased homeopathic remedies that were the subject of a Sept. 2016 FDA warning.

While the agency’s warning resulted in the withdrawal of affected products from store shelves, the suit alleges that consumers were never offered refunds. Defendants named in the case include Hyland’s Inc., Church & Dwight Co. Inc., Standard Homeopathic Co., CVS Health Corp., and Target Corp.

Hyland’s Baby Teething Tablets Linked to 10 Children’s Deaths, Hundreds of Injuries

October 13, 2016 – At least 400 adverse event reports — including the deaths of 10 children — have been linked to the use of homeopathic teething tablets, according to the U.S. Food and Drug Administration (FDA) [2].

The agency warned caregivers to stop using the products and to take their child to a doctor immediately if he or she experiences problems.

Read more about the other defective pharmaceutical lawsuits from S&C Law Firm.

What is the Statute of Limitations in a Teething Tablets Lawsuit?

The statute of limitations for belladonna toxicity is complex, which is why it is always best to contact a belladonna toxicity injury lawyer to discuss your case.

In most cases, the statute of limitations for benzocaine-related teething tablet injuries is 2 years. For example, if your child died from benzocaine poisoning, then you have two years from the date of death to file a wrongful death claim.

Other situations to file a claim include:

• Once a child turns 18, they have two years to file a claim for injuries caused by benzocaine or belladonna.
• Parents have two years from the FDA’s January 2017 announcement to file a claim if their child suffered injury or death from belladonna.

The two-year statute of limitations is coming up soon. If you suffered injury or death as a result of Hyland’s homeopathic teething tablets or gel, contact a teething remedies lawsuit attorney.

Action Steps for Parents Regarding Hyland’s Teething Tablets Recall Lawsuit

If you are a parent concerned about the potential risks associated with Hyland’s teething tablets, particularly in light of the recall and ongoing lawsuits, here are clear action steps to take:

1. Stop Using the Product Immediately

Discontinue the use of Hyland’s teething tablets or any other affected products right away to prevent further exposure to potentially harmful ingredients.

2. Document All Symptoms

Keep a detailed record of any symptoms your child has experienced that may be related to using the teething tablets. Include dates, descriptions of symptoms (e.g., irritability, rash, fever), and any changes in behavior.

3. Keep Product Packaging

Retain all packaging and labels from the teething tablets. This information may be important for any future legal claims or medical consultations.

4. Gather Medical Records

Collect all relevant medical records related to your child’s health, including doctor visits, diagnoses, and treatments that the use of the product may have influenced. This documentation can be crucial for both medical and legal purposes.

5. Contact Pediatrician

Schedule an appointment with your child’s pediatrician to discuss any symptoms or concerns you have. The pediatrician can provide guidance on how to manage symptoms and assess any potential long-term effects.

6. Seek Legal Consultation

Consider consulting with a lawyer specializing in product liability or consumer protection cases. They can help you understand your rights, evaluate any potential claims related to the teething tablets, and guide you through the legal process if necessary.

Taking these action steps can help ensure your child’s safety and well-being in light of the concerns surrounding Hyland’s teething tablets. By documenting symptoms, retaining product information, seeking medical advice, and exploring legal options, you can advocate effectively for your child’s health and rights.

FAQs

What should I look for in a lawyer for a teething tablet recall lawsuit?

Look for a lawyer with experience in product liability and pharmaceutical cases, a strong track record of successful settlements or verdicts, and a thorough understanding of FDA regulations and safety standards.

Are there safer alternatives to recalled teething tablets?

Yes, there are safer alternatives such as teething rings, gentle gum massages, and cold washcloths. Consult with your pediatrician for recommendations on safe teething remedies.

What are the common ingredients in teething tablets that pose risks?

Common ingredients that pose risks include belladonna alkaloids, which can be toxic in large or inconsistent doses, and other contaminants that may be introduced during manufacturing.

How do manufacturing practices affect the safety of teething tablets?

Inadequate manufacturing practices can lead to contamination, inconsistent dosing of active ingredients, and overall poor product quality, increasing the risk of adverse reactions in infants.

Get a Free Homeopathic Teething Tablets Lawsuit Evaluation With Our Lawyers

The Product Liability Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in teething tablet lawsuits. We are handling individual litigation nationwide and currently accepting new injury and death cases in all 50 states.

Free Case Evaluation: Again, if your child was injured by teething tablets, you should contact our law firm immediately. You may be entitled to a settlement by filing a suit and we can help.