A baby sleep product is being recalled after testing found several forms of alcohol that were not listed on the label, according to a notice from the Food and Drug Administration (FDA).
Pacific Health Sciences is voluntarily recalling one batch of Babies’ Magic Tea brand Baby Sleep Gripe Water after tests detected ethanol, methanol and isopropanol in the product.
The FDA said those substances were not declared on the label.
Testing found approximately 8.3% ethanol, 0.35% methanol and 0.48% isopropanol.
The agency warned that the substances could pose health risks depending on how much is consumed, as well as the age and body weight of the person taking the product.
The concern is especially serious because the product is intended for babies.
According to the recall notice, the alcohols can interfere with normal central nervous system function.
The FDA also noted that infant exposure to ethanol has been linked to potential long-term developmental consequences.
Even at the recommended dose, the notice said exposure could cause symptoms including drowsiness, poor coordination, behavioral changes, nausea, vomiting and abdominal pain.
Taking more than the recommended amount could increase the risk of more serious effects.
The FDA warned that higher exposure could potentially lead to respiratory depression and other significant health complications.
So far, the company has not received any reports of injuries or other adverse events connected to the recalled product.
The affected batch carries Lot Number 25122bw and a “Best Before” date of December 2028.
The recalled product was distributed to a company called Secrets of Tea.
It was sold online through that company’s website as well as through Amazon.
Consumers who have the recalled product are being told not to use it.
They can return it for a refund or dispose of it.
The recall also renews concerns about gripe water products more broadly.
Gripe water is commonly marketed to parents as a way to help babies with colic, gas and fussiness.
Typical ingredients can include fennel, ginger, baking soda and various flavorings.
However, questions remain over how effective such products actually are.
The Cleveland Clinic has previously warned that herbal remedies are not subject to the same level of government oversight as food or medicine, per the Western Journal.
That means parents may have less assurance about the quality and consistency of some gripe water products.
The clinic has also noted that multiple gripe water brands have been recalled over the years because of safety concerns.
There is also limited research showing that gripe water actually works as advertised.
Dr. Christina Vernace said ingredients such as ginger and fennel may help stomach discomfort in adults and children, but that does not mean the same benefits have been proven in infants.
“Ginger and fennel can relieve stomach discomfort in adults and kids, but babies’ bellies are different,” Vernace said.
She added that those ingredients have not been shown to work in babies.
Vernace also noted that colic is a complicated condition and is not necessarily caused by stomach discomfort.
As a result, ingredients aimed at easing digestion may not actually address the underlying cause of a baby’s crying or fussiness.
For now, the immediate concern is the recalled lot of Babies’ Magic Tea Baby Sleep Gripe Water.
Parents and caregivers are being urged to check the lot number and best-before date on any product they may have at home.
If it matches the recalled batch, the product should not be given to a baby.
