Standard Homeopathic Company is recalling all of its Hyland’s Baby Teething Tablets and Hyland’s Baby Nighttime Teething Tablets nationwide. The U.S. Food & Drug Administration has concluded that the medicines have been found to contain inconsistent amounts of an herb that may differ from the calculated amount on the products’ labels and could potentially be dangerous.
That herb is belladonna which has been used as a homeopathic medicine for many years but its scientific evidence of recommended use is insufficient. Because the effects of belladonna are unpredictable, the FDA believes that belladonna represents a serious health hazard to children. The FDA stated that “there is no known safe dose or toxic dose of belladonna in children because of the many factors that affect it.”
The FDA began investigating the products after receiving a September 2016 comprehensive report of a child having a seizure after using one. An FDA preliminary investigation found reports of adverse effects, including 10 possible deaths, seizures, shortness of breath and tremor. Standard Homeopathic Company stopped making and shipping the medicines nationwide in October 2016.
The Teething Tablets were used to provide temporary relief of teething symptoms in small children. This recall includes all products that retailers may have had in stock. Consumers who have the products which are being recalled should discard the product.
Consumers with questions regarding this recall can contact Standard Homeopathic Company by calling 1-800-991-3376 (Monday-Friday 6 a.m. to 4 p.m. Pacific Time). Consumers should contact their physician or healthcare provider if they believe they have experienced any problems that may be related to taking or using this drug product.
Adverse reactions or quality problems experienced with the use of these products may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Complete and submit the report Online: fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form fda.gov/MedWatch/getforms.htmor 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.