FDA Issues Consumer Safety Alert: Hylands Teething Tablets

The U.S. Food and Drug Administration today is warning consumers that Hyland’s Teething Tablets may pose a risk to children. The FDA recommends that consumers not use this product and dispose of any in their possession. The manufacturer is issuing a recall of this product.

Hyland’s Teething Tablets are manufactured to contain a small amount of belladonna, a substance that can cause serious harm at larger doses. For such a product, it is important that the amount of belladonna be carefully controlled. FDA laboratory analysis, however, has found that Hyland’s Teething Tablets contain inconsistent amounts of belladonna. In addition, the FDA has received reports of serious adverse events in children taking this product that are consistent with belladonna toxicity. The FDA has also received reports of children who consumed more tablets than recommended, because the containers do not have child resistant caps.

The 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, difficulty urinating, or agitation after using Hyland’s Teething Tablets.

Hyland’s Teething Tablets is a homeopathic product intended to provide temporary relief of teething symptoms in children that is sold over-the-counter (OTC) in retail outlets.  The FDA has not evaluated Hyland’s Teething Tablets for  safety or efficacy, and is not aware of any  proven clinical benefit offered by the product.

An ongoing inspection at the manufacturer also indicates substandard control of the manufacturing operation. After consultation with the FDA today, the manufacturer of the product, Standard Homeopathic Company agreed to voluntarily recall Hyland’s Teething Tablets from the market.

FDA urges both health care professionals and consumers to report side effects from use of Hyland’s Teething Tablets to the FDA’s MedWatch Adverse Event Reporting program either:

  • Complete and submit the report online: www.fda.gov/MedWatch/report.htm
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Update:

The Hyland’s Teething Tablets UPC codes included in the recall are:

1. Hyland’s Teething Tablets, 125 tablets, UPC # 3 54973 75041
2. Hyland’s Teething Tablets, 250 tablets, UPC # 3 54973 75042
3. Hyland’s Teething Tablets, 125 tablets, UPC # 3 54973 75066
4. Hyland’s Teething Tablets, 50 tablets, UPC # 3 54973 75044
5. Hyland’s Teething Tablets, 145 tablets, UPC # 3 54973 75121
6. Hyland’s Teething Tablets, Clip Strip 6×125 tablets, UPC # 3 54973 35109

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Baby Gizmo founder Hollie Schultz is the proud mom of three adorable kids. This certified CPS (Child Passenger Safety) Tech and baby gear expert is the host of the Baby Gizmo video reviews giving moms the inside look at baby products before they purchase them. Hollie is also the co-author of The Baby Gizmo Buying Guide. A former resident of Los Angeles, she and her family now live in North Carolina where she is having a blast designing and decorating her new home.

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2 Comments on "FDA Issues Consumer Safety Alert: Hylands Teething Tablets"

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Claudia
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A friend turned me onto this product. It provides my baby with much needed relief and without adverse reactions. I use another Hyland’s product myself and it has provided more relief than what my doctor was prescribing me. Homeopathic remedies are diluted preparations. The FDA never approves natural or alternative remedies, all which have been around long before the FDA was created. The FDA does not endorse acupuncture, a healing art that’s over 2000 years old. Insurance companies do not cover alternative therapies, even though they have been proven to heal individuals. Perhaps healing individuals is not in the FDA’s… Read more »
Charissa
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We used these for our 2.5 yo twins followed the dosage on the labelling and had no adverse reactions. We stored the bottles out of reach of children but at the age they needed them, they couldn’t even reach a counter top! Maybe we were lucky. But they did seem to give our girls some relief…

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