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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 Oct. 6 and published by the U.S. Food and Drug Administration (FDA) the following day.
The recall affects Lot 25122bw, which has a best-before date of December 2028.
The recalled product comes in a 4-ounce amber bottle packaged inside a blue cardboard box with an oral syringe. The lot number appears on the bottom of the box and on a side panel of the bottle.
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Parents and caregivers are being urged to stop using a baby product sold online after testing found undeclared alcohol. (U.S. Food and Drug Administration)
The product is marketed on its packaging as helping babies with “better sleep,” as well as providing relief from gas, bloating, constipation and acid reflux.
FDA testing found the recalled product contained approximately 8.3% ethanol, 0.35% methanol and 0.48% isopropanol, none of which were listed on the label, according to the recall notice.
“These substances were not listed on the label,” the 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.”
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FDA testing found the recalled product contained approximately 8.3% ethanol, 0.35% methanol and 0.48% isopropanol, none of which were listed on the label. (U.S. Food and Drug Administration)
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.
The company added, “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.
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The affected gripe water was distributed to Secrets of Tea and later sold through online retailers, including the Secrets of Tea website and Amazon. (iStock)
The affected gripe water was distributed to Secrets of Tea and later sold through online retailers, including the Secrets of Tea website and Amazon.
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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, according to the notice.
“Anyone who experiences symptoms after using the product should seek medical attention and contact Pacific Health Sciences,” the company added.
Pacific Health Sciences could not immediately be reached by FOX Business for comment.
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