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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 the presence of 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 released by the U.S. Food and Drug Administration (FDA) the next day.
The recall concerns lot 25122bw, which has an expiration date of December 2028.
The recalled product comes in a 4-ounce amber bottle packaged in a blue cardboard box containing 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 carers are being urged to stop using a baby product sold online after tests revealed the presence of undeclared alcohol. (US Food and Drug Administration)
The product is marketed on its packaging as helping babies “sleep better,” while also relieving gas, bloating, constipation and acid reflux.
FDA testing found that 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 present a risk depending on the quantity consumed as well as the age and weight of the person using the product.”
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FDA testing found that the recalled product contained approximately 8.3% ethanol, 0.35% methanol, and 0.48% isopropanol, none of which were listed on the label. (US Food and Drug Administration)
The company warned that exposure to the amounts recommended on the package 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 exposure to ethanol has been associated with long-term developmental consequences,” the advisory states.
The company added: “Exposure to higher amounts may increase the risk of respiratory depression and other serious adverse health consequences. »
No adverse events associated with the recalled lot were reported to Pacific Health Sciences at the time of recall notification.
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The affected water was distributed to Secrets of Tea and then sold through online retailers including the Secrets of Tea website and Amazon. (iStock)
The affected water was distributed to Secrets of Tea and then sold through online retailers including the Secrets of Tea website and Amazon.
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Anyone who purchased the recalled product should stop using it immediately and throw it away or return it to the place of purchase for a refund, according to the notice.
“Anyone experiencing symptoms after using the product should seek medical attention and contact Pacific Health Sciences,” the company added.
FOX Business could not immediately reach Pacific Health Sciences for comment.
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