Baby Sleep Gripe Water Recalled After FDA Finds Undeclared Alcohol in Product Marketed for ‘Better Sleep’

Parents and caregivers are being urged to stop using a recalled lot of a baby product sold online after federal testing found undeclared alcohol. Pacific Health Sciences is voluntarily recalling one lot of Babies’ Magic Tea brand Baby Sleep Gripe Water, a dietary supplement sold in 4-ounce bottles, according to an announcement dated October 6 and published by the U.S. Food and Drug Administration the following day. The recall affects Lot 25122bw, which has a best-before date of December 2028. The product, marketed on its packaging as helping babies with “better sleep” as well as providing relief from gas, bloating, constipation, and acid reflux, was found to contain approximately 8.3% ethanol, 0.35% methanol, and 0.48% isopropanol—none of which were listed on the label.

“These substances were not listed on the label,” the recall notice states. “Their presence may pose a risk depending on the amount consumed and the age and body weight of the person using the product.” The company warned that exposure to the amounts recommended on the packaging could cause drowsiness, lack of coordination, behavioral changes, nausea, vomiting, and abdominal pain. “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,” the notice said. “Exposure to higher amounts can increase risk of respiratory depression and other serious adverse health consequences.” No adverse events associated with the recalled lot had been reported to Pacific Health Sciences as of the recall notice. The affected gripe water was distributed to Secrets of Tea and later sold through online retailers, including the Secrets of Tea website and Amazon. Anyone who has purchased the recalled product should stop using it immediately and either throw it away or return it to the place of purchase for a refund. “Anyone who experiences symptoms after using the product should seek medical attention and contact Pacific Health Sciences,” the company added.