Baby sleep product recalled after FDA finds 3 types of alcohol not listed on label

Parents and caregivers are being advised to cease usage of a specific batch of a baby product sold online following the discovery of undeclared alcohol by federal authorities. Pacific Health Sciences has initiated a voluntary recall of one lot of Babies' Magic Tea brand Baby Sleep Gripe Water, a dietary supplement offered in 4-ounce bottles. This announcement was made on October 6 and subsequently published by the U.S. Food and Drug Administration (FDA) the following day.

The recall pertains to Lot 25122bw, which has a best-before date set for December 2028. The affected product is packaged in a 4-ounce amber bottle placed inside a blue cardboard box, which also includes an oral syringe. Consumers can find the lot number printed on the bottom of the box as well as on a side panel of the bottle.

This product is marketed as a remedy to assist babies in achieving "better sleep" and also claims to alleviate issues such as gas, bloating, constipation, and acid reflux. However, testing conducted by the FDA revealed that the recalled batch contained approximately 8.3% ethanol, 0.35% methanol, and 0.48% isopropanol, none of which were disclosed on the product's label.

The recall notice emphasized that the presence of these substances, which were not mentioned on the label, could pose health risks based on the amount consumed, as well as the age and weight of the individual using the product. The company cautioned that exposure to the recommended dosage could lead to symptoms such as 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 explained. It also warned that higher levels of exposure could heighten the risk of respiratory depression and other serious health issues.

As of the date of the recall notice, Pacific Health Sciences reported that no adverse effects related to the recalled lot had been documented. The affected gripe water was distributed to Secrets of Tea and subsequently sold through various online platforms, including the Secrets of Tea website and Amazon.

Consumers who have purchased the recalled product are urged to stop using it immediately. They can either dispose of it or return it to the point of purchase for a refund. The notice also advised that anyone experiencing symptoms after using the product should seek medical attention and contact Pacific Health Sciences directly.

Attempts to reach Pacific Health Sciences for further comments were unsuccessful as of the time of this report.