Baby sleep product recalled due to unlabeled presence of three types of alcohol, FDA reports

The U.S. Food and Drug Administration (FDA) has reported a significant recall of a baby product due to health concerns. Parents and caregivers are being advised to cease using a specific lot of a dietary supplement marketed as Babies’ Magic Tea Baby Sleep Gripe Water. This product, sold in 4-ounce bottles, has been recalled after federal testing uncovered the presence of undeclared alcohol substances that may pose health risks.

Pacific Health Sciences, the manufacturer of the product, has voluntarily initiated the recall for Lot number 25122bw, which has a best-before date of December 2028. The affected product is contained in an amber bottle accompanied by a blue cardboard box and an oral syringe. Both the lot number and product information can be found on the packaging.

The FDA’s evaluations revealed troubling findings: the recalled batch of gripe water contained approximately 8.3% ethanol, 0.35% methanol, and 0.48% isopropanol—none of which were disclosed on the product label. These chemicals have the potential to impair the central nervous system’s normal functioning and carry serious health risks, particularly for infants.

The potential adverse effects for consumers include drowsiness, lack of coordination, behavioral changes, nausea, vomiting, and abdominal pain. Exposure to these substances, especially in the quantities recommended on the product packaging, could lead to more severe health consequences such as respiratory depression.

Although Pacific Health Sciences states that no adverse events related to the recalled lot have been reported as of the recall notification, they are advising anyone who purchased the product to discontinue use immediately. Consumers can either dispose of the product or return it to the place of purchase for a full refund. The company has urged individuals who experience any symptoms after using the product to seek medical attention and to contact them for further guidance.

The affected gripe water was distributed to Secrets of Tea and made available through various online retailers, including Amazon. Consumers should be vigilant about the products they purchase, particularly baby supplements, to ensure safety and avoid potential health risks.

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