FDA recalls baby sleep aid after investigation finds 3 toxic alcohol ingredients not listed on label

A popular baby sleep remedy could be hazardous to infants. 

A baby product sold online is being voluntarily recalled after federal testing discovered undeclared alcohols, prompting health officials to urge parents and caregivers to immediately stop using it.

Pacific Health Sciences issued the voluntary recall for Lot 25122bw of its Babies’ Magic Tea brand Baby Sleep Gripe Water after Food and Drug Administration (FDA) testing revealed the presence of toxic, unlabeled alcohols.

FDA testing uncovered ethanol, methanol, and isopropanol in the product – none of which were listed on the label. Lab measurements detected concentration levels of roughly 8.3% ethanol and 0.35% methanol, along with 0.48% isopropanol.

Exposure to these alcohols poses severe health risks to infants, with the potential to depress central nervous system functions depending on consumption volume and age. An infant’s body weight can also affect the product’s influence, the agency warned.

In a health hazard warning, the FDA cautioned that infant exposure to ethanol is linked to long-term developmental issues, including impaired coordination and behavioral changes. Immediate physical symptoms can include drowsiness and nausea or vomiting.

The recalled gripe water was packaged in 4-fluid-ounce (118 ml) amber bottles inside blue cardboard boxes and shipped with an oral syringe.

Officials added that ingesting elevated amounts can also heighten the risk of dangerous respiratory depression.

The affected batch was sold nationwide online via Amazon and distributed to Secrets of Tea, an organic herbal remedies retailer, where it was available on its website.

Marketed as an over-the-counter liquid herbal supplement, the product is sold to soothe infant gas and hiccups using ingredients like ginger root and sodium bicarbonate (baking soda).

Its sleep support stems from a proprietary “bedtime blend” containing chamomile and lemon balm, along with passionflower to promote relaxation.

No adverse events or injuries have been reported to date in connection with the recall.

Parents have long held mixed opinions about using herbal sleep blends for infants, though some praise their effectiveness for gas and restless nights.

“Our baby loved this stuff for the first two months,” one parent wrote on Reddit’s New Parents thread. “She would be crying from gas pains and upset tummy, and as soon as she would get the gripe water [she’d calm down].”

Other parents express concern over using supplements that lack official FDA approval or worry about relying on them as a shortcut.

“Sometimes I literally feel bad and that I’m taking the easy way out, but sometimes it’s the only way to calm down the witching hour enough for her to relax and drink her bottle,” another parent shared on the forum.

And some social media users are passing judgement, “Who the f gives sleep products to babies???” commented one Instagram user on @foxbusiness.

“We used baby bliss gripe water once for gas and it knocked my baby out. Will never use it again,” commented another.

The FDA strongly advises consumers to immediately stop using the product and either discard it or return it to the point of purchase for a full refund.

Pacific Health Sciences can be reached by phone at (310) 457-1775 or by email at myorder@pacifichealth.com, Monday through Thursday from 9:30 a.m. to 5 p.m. PT. Company representatives did not immediately respond to requests for comment.