FDA Recalls Baby Sleep Gripe Water Lot Over Undeclared Alcohol Levels

Parents and caregivers are being urged to stop using a recalled lot of a baby product sold online after federal testing identified undeclared alcoholic substances.

Pacific Health Sciences announced a voluntary recall of one lot of Babies’ Magic Tea brand Baby Sleep Gripe Water, a dietary supplement packaged in 4‑ounce bottles. The recall notice, dated Oct. 6, was published by the U.S. Food and Drug Administration the following day.

The affected lot is identified as Lot 25122bw, with a best‑before date of December 2028. The product is sold in a 4‑ounce amber bottle contained within a blue cardboard box and includes an oral syringe. The lot number is printed on both the box bottom and the bottle side panel.

The labeling promotes the supplement as aiding “better sleep” and providing relief from gas, bloating, constipation and acid reflux.

FDA laboratory analysis revealed that the recalled product contains approximately 8.3 % ethanol, 0.35 % methanol and 0.48 % isopropanol—substances not listed on the product’s 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 manufacturer warned that exposure to the recommended dosage 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 that higher exposures may increase the risk of respiratory depression and other serious adverse health effects.

To date, no adverse events linked to this lot have been reported to Pacific Health Sciences.

The product was distributed to Secrets of Tea and subsequently sold through online retailers, including the Secrets of Tea website and Amazon.

Consumers who have purchased the recalled lot should discontinue use immediately and either discard the product or return it to the point of purchase for a refund. Anyone experiencing symptoms after using the product should seek medical attention and contact Pacific Health Sciences.

Pacific Health Sciences could not be reached for immediate comment.

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