Standard Homeopathic Company, in consultation with the US Food and Drug Administration (FDA), is voluntarily recalling its Hyland’s Teething tablets. The company is initiating this recall in an abundance of caution due to an FDA investigation of its manufacturing facility. Hyland’s Teething tablets are manufactured in the United States and distributed throughout North America.

The Hyland’s Teething tablets UPC codes included in the recall are: 125 tablets, UPC # 3 54973 75041; 250 tablets, UPC # 3 54973 75042; 125 tablets, UPC # 3 54973 75066; 50 tablets, UPC # 3 54973 75044; 145 tablets, UPC # 3 54973 75121 and Clip Strip 6x125 tablets, UPC # 3 54973 35109.

Adverse events have been reported but the FDA has said that a conclusive link has not been determined. The company, in working with the FDA, has identified manufacturing processes of Teething Tablets that can be improved to ensure uniformity in dosage. As a homoeopathic product, Hyland’s Teething tablets have a wide margin of safety that protects consumers from harm.

After in-depth analysis, a comprehensive review of the company’s adverse event report log, and more than 85 years of safe usage, the company is confident that Hyland’s Teething tablets are safe for infants and toddlers.

In addition to the product recall, Standard Homeopathic Company is refining its production, packaging and testing protocols. Throughout the process, Standard Homeopathic Company will continue to closely monitor and evaluate the situation and consult with FDA.

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).

“We initiated this voluntary recall to ensure our consumers know that their families’ safety and health are our top priorities,” said Mark Phillips, PharmD, president and chief pharmacist of Standard Homeopathic Company. “We are committed to maintaining and deserving the trust they have placed in Hyland’s. We have worked for 107 years to build relationships with our consumers. We intend to preserve that tradition of trust.”

Hyland’s Teething tablets is a homoeopathic product intended to provide temporary relief of teething symptoms in children that is sold over-the-counter (OTC) in retail outlets.

Standard Homeopathic Company develops and manufacturers lines of homoeopathic medicines, including its top-selling Hyland’s brand. Hyland’s homoeopathic formulas are manufactured with the highest quality natural ingredients following the strictest standards of preparation.