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 recetly 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.

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 pose a risk to 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, it is important that the amount of belladonna 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, more popularly known as nightshade, is a plant with known toxic effects. The plant is found in parts of Europe, Africa and Asia. The leaves and roots of the poisonous belladonna plant are ingredients in an array of medicines.

These medicines include sedatives, treating bronchial spasms and cold homeopathic teething remedies. Until 2017, Belladonna was the main ingredient in Hyland’s dissolvable homeopathic remedies.

Certain homeopathic teething products have been around since the early 1900s. Use of toxic substances to treat illnesses or ailments is a form of natural, or holistic, medicinal approach to healing called homeopathy. Homeopathy is a 200-year-old system of alternative medicine based on the belief that body can cure itself.

Those who use it, believe that tiny amount of natural, toxic substances from plants and minerals that would normally cause symptoms of disease in healthy people, can cure symptoms in sick people.

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, after a 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 risks 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.

By using words like “natural,” Hyland was able to 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 is the part of the brain that 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 found in the company’s teething products were a serious health hazard. The company initially declined to recall its homeopathic teething products.

In fact, 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 voluntarily issue a teething tablet recall. 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 your child in pain. However, parents should always be mindful of the possible dangers the medication they administer to their children pose. 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 to relieve 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, as 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. Having objects in the mouth, such as teething rings or fingers, produces 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 the teething process, children’s Tylenol or children’s 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, if your baby develops a fever, or seems particularly uncomfortable, contact your doctor. 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 [1] has revealed inconsistent amounts of belladonna — sometimes far exceeding the amount printed on the labeling — in homeopathic medicines. The agency is warning that teething tablets pose an unnecessary risk to infants and children, and recommends that consumers avoid the products.

Baby Nighttime Teething Tablets Class Action Filed in New York

January 4, 2017 – A lawsuit has been filed in New York on behalf of 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 for their purchases. 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.

What is the Statute of Limitations for a Homeopathic Teething Tablet Lawsuit?

The time to hold a company accountable for its negligence through a civil lawsuit is short. Because of this, it is important to contact a Hyland’s Lawsuit lawyer right away. The Carlson Law Firm is accepting cases from families across the country on behalf of children who have suffered injury as a result of benzocaine poisoning. If your child suffered an injury from Hyland’s Homeopathic Teething Tablets or teething gels.

Further, if your child developed any of the symptoms consistent with belladonna overdose, contact our firm to schedule a free drug evaluation.

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.