PLEASE NOTE: Hyland has made changes to and re-issued this product. For details, please visit http://www.hylandsteething.com/recall/.
Standard Homeopathic Company is voluntarily recalling its Hyland's Teething Tablets, a homeopathic product intended to provide temporary relief of teething symptoms in children that is sold over-the-counter in retail outlets. The U.S. Food and Drug Administration is warning consumers that the recalled tablets may pose a risk to children.
The Hyland's Teething Tablets UPC codes included in the recall are:
Hyland's Teething Tablets, 125 tablets, UPC # 3 54973 75041
Hyland's Teething Tablets, 250 tablets, UPC # 3 54973 75042
Hyland's Teething Tablets, 125 tablets, UPC # 3 54973 75066
Hyland's Teething Tablets, 50 tablets, UPC # 3 54973 75044
Hyland's Teething Tablets, 145 tablets, UPC # 3 54973 75121
Hyland's Teething Tablets, Clip Strip 6x125 tablets, UPC # 3 54973 35109
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. Any adverse reactions may also be reported to the FDA's MedWatch Program by fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.
Consumers that are concerned about the safety of the product may contact Standard Homeopathic Company for instructions on a refund or replacement product. For these instructions or information regarding how to return or dispose of the product, consumers should log on to www.hylandsteething.com/recall or call 1-877-496-5044 (Monday-Friday 8 a.m. to 10 p.m. Eastern Time, and Saturday-Sunday 9 a.m. to 5 p.m. Eastern Time).