FDA Testing Triggers Recall of Baby Sleep Gripe Water

Parents and caregivers are being warned to stop using a baby sleep supplement after federal testing detected three types of alcohol that were not disclosed on its label. Pacific Health Sciences is voluntarily recalling one lot of Babies' Magic Tea brand Baby Sleep Gripe Water, sold in 4-ounce bottles, because the undeclared ingredients could pose health risks to infants, according to a recall notice dated October 6 and published by the U.S. Food and Drug Administration (FDA) the following day.

The recall covers Lot 25122bw, which has a best-before date of December 2028. The affected product was distributed to Secrets of Tea and subsequently sold through online retailers, including the Secrets of Tea website and Amazon, according to the recall notice.

FDA testing found approximately 8.3% ethanol, 0.35% methanol and 0.48% isopropanol in the recalled product. None of the three substances appeared on the product label, the agency's notice stated.

The recall notice warned that the health risks depend on how much of the product a person consumes, as well as the user's age and body weight.

"These substances were not listed on the label. Their presence may pose a risk depending on the amount consumed and the age and body weight of the person using the product," the recall notice stated.

The company said exposure to the amounts recommended on the packaging could cause drowsiness, impaired coordination, behavioral changes, nausea, vomiting and abdominal pain. The product was marketed as supporting better sleep in babies and relieving gas, bloating, constipation and acid reflux.

Pacific Health Sciences also highlighted the potential effects of alcohol exposure on the nervous system and the particular concerns associated with infants.

"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 further warned that more substantial exposure could lead to serious medical complications.

"Exposure to higher amounts can increase risk of respiratory depression and other serious adverse health consequences," the notice stated.

As of the recall announcement, Pacific Health Sciences had not received reports of adverse events associated with the affected lot, according to the company.

The recalled product is packaged in an amber 4-ounce bottle inside a blue cardboard box and comes with an oral syringe. Consumers can identify the affected lot number on the bottom of the box and on a side panel of the bottle.

According to the recall notice, consumers who purchased the affected product should discontinue use and either discard it or return it to the place of purchase for a refund. The company also advised people who experience symptoms after using the product to seek medical attention and contact Pacific Health Sciences.

FOX Business reported that Pacific Health Sciences could not immediately be reached for comment.