(FOX 13) - Hyland's Baby Teething Tablets are being recalled because they contain inconsistent amounts of belladonna alkaloids and could pose serious health hazards to babies and children.
Standard Homeopathic Company is recalling all lots of Hyland’s Baby Teething Tablets and Hyland’s Baby Nighttime Teething Tablets after the FDA found the amounts of belladonna alkaloids in the tablets may not match what's printed on the label, and from tablet to tablet.
The FDA said it believes belladonna represents a serious health hazard to children and that the effects of belladonna are unpredictable.
The recall includes all products that retailers may have had in stock. The company stopped making and shipping the medicines nationwide in October 2016. This recall ensures the removal of any possible remaining products that may be on store shelves.
No other Standard Homeopathic Company/Hyland’s products are affected by the recall.
Consumers with questions about 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:
- Online www.fda.gov/medwatch/report.htm
- By mail or fax: Download form www.fda.gov/MedWatch/getforms.htm 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.