A baby sleep supplement is being recalled after undeclared alcohol content was found in the product.
Pacific Health Sciences is voluntarily recalling one lot of its Babies’ Magic Tea brand Baby Sleep Gripe Water dietary supplement, the Food and Drug Administration (FDA) announced Wednesday.
FDA testing identified ethanol, methanol, and isopropanol that were not on the label.
“Measured levels were approximately 8.3% ethanol, 0.35% methanol, and 0.48% isopropanol,” officials stated.
The alcohols could pose a risk for infants depending on the amount consumed and their age and body weight, according to the FDA.
“Organic alcohols such as ethanol, methanol, and isopropanol are known to impair normal functioning of the central nervous system, while infant ethanol exposure has been linked to long-term developmental consequences,” officials stated.
Recalled supplement poses health risks even at recommended amounts
Taking the recommended amount listed on the packaging can cause sleepiness, trouble with coordination, changes in behavior, nausea, vomiting, and stomach pain. Taking more can increase the risk of dangerously slowed breathing and other serious health problems.
The FDA noted that Pacific Health Sciences has not received any reports of adverse effects associated with the batch.
The products were distributed to Secrets of Tea for sale through online retailers, including on www.secretsoftea.com and Amazon.
Consumers are urged to stop using the products from Lot 25122bw and to either throw them away or return them for a refund.
Officials said anyone who experiences symptoms from using the product should seek medical attention and contact Pacific Health Sciences at 310-457-1775 or myorder@pacifichealth.com, Monday through Thursday, 9:30 a.m. to 5 p.m. Pacific Time.