Update: FDA Cites Teething Tablet Manufacturer for GMP Violations
June 27, 2017 – An FDA warning letter sent Tuesday to Raritan Pharmaceuticals — the New Jersey CMO that manufactured Hyland’s 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.
What’s the problem?
October 13, 2016 – FDA advised parents and caregivers to stop using teething tablets, which are mainly distributed by CVS and Hylands, and to take their child to a doctor immediately if he or she has a problem.
“The U.S. Food and Drug Administration is warning consumers that homeopathic teething tablets and gels may pose a risk to infants and children,” the agency said. “The FDA recommends that consumers stop using these products and dispose of any in their possession.”
FDA recommends seeking immediate medical care if children exhibit any of the following symptoms after using teething tablets:
- Seizures
- Difficulty breathing
- Lethargy
- Excessive sleepiness
- Muscle weakness
- Skin flushing
- Constipation
- Difficulty urinating
- Agitation
Hyland’s Teething Tablets Recall
In October 2010, FDA warned consumers to stop using and discard Hyland’s Teething Tablets after the agency received multiple adverse event reports associated with a potentially toxic ingredient called belladonna in the product. Hyland’s responded by recalling its teething tablets and reformulating them to reduce the amount of belladonna. FDA’s most recent warning has not led to another recall of the products.
Benzocaine in Teething Remedies Linked to methemoglobinemia: FDA
In April 2011, FDA warned about the risks of using benzocaine teething remedies on very young children. According to the agency, studies have linked benzocaine to an increased risk for methemoglobinemia, a potentially life-threatening blood disorder that causes symptoms including cyanosis (blue tint to the skin, lips and nail beds), headache, lightheadedness, shortness of breath, fatigue and rapid heart rate.
Benzocaine products used to treat teething pain in children are sold under the following brand names:
- Anbesol
- Hurricane
- Orajel
- Baby Orajel
- Orabase
- numerous store brands
Natural Teething Remedies
“Teething can be managed without prescription or over-the-counter remedies,” said Janet Woodcock, M.D., director of 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.”
Natural alternatives that can help soothe teething babies include:
- Frozen things (washcloths, carrots, celery)
- Mesh teething feeder
- Amber necklace
- Facial / gum massage
Hyland’s Teething Tablets Recalled in Australia
May 2, 2017 – Australia’s Therapeutic Goods Administration (TGA) has issued a recall for Hyland’s Baby Teething Tablets and Hyland’s Baby Nighttime Teething Tablets 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, will no longer be sold in Australia.
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 teething tablets. The agency is warning that teething tablets pose an unnecessary risk to children and infants, and recommends that consumers avoid the products.
Teething Tablets Class Action Filed in New York
January 4, 2017 – A teething tablets lawsuit has been filed in New York on behalf of consumers who purchased homeopathic remedies that were the subject of a Sept. 2016 warning by the FDA. 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.
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
Do I Have a Teething Tablets Lawsuit?
The Class Action Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in teething tablets 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 lawsuit and we can help.