A popular nighttime remedy for babies that’s meant to help with gas and fussiness has been recalled, with the Food and Drug Administration saying it contains levels of ethanol, methanol and isopropanol that weren’t listed on the label.
According to an Oct. 6 announcement, one lot of Babies’ Magic Tea brand Baby Sleep Gripe Water has been recalled by Pacific Health Sciences. The 4 fl. oz. bottles, with lot number 25122bw, were sold nationwide on Amazon and other online retailers, the announcement said.
As of Thursday, the product appeared to be pulled from Amazon’s website.
The bottles were recalled after FDA testing found the supplement contained ethanol, methanol and isopropanol that had not been declared on the label. Measured levels were approximately 8.3% ethanol, 0.35% methanol and 0.48% isopropanol, the FDA said.
“Their presence may pose a risk depending on the amount consumed and the age and body weight of the person using the product,” the announcement said.
Ethanol, methanol, and isopropyl may be used as preservatives or solvents in some drugs, medications and household products.The FDA’s approved amount of ethanol as an excipient, or inactive ingredient, in oral over-the-counter products is 0.5% for children under 6 years of age, a 2025 study from the National Institute of Health said.
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“It is vital to clearly state the concentrations of potentially toxic excipients including ethanol,” the study said.
The approximately 118 mL amber bottles, with a best before date of 12/2028, were sold inside small blue cardboard boxes with oral syringes included. Parents and caregivers can identify the recalled product by the lot number, which appears on the bottom of the box and on a side panel of the bottle.
“Consumers, parents, and caregivers should stop using any product from Lot 25122bw and either discard it or return it to the place of purchase for a refund,” the announcement said. To date, Pacific Health Sciences received no reports of adverse health events related to the recall.
Gripe water is a common over-the-counter supplement that claims to help relieve symptoms of gas, colic and fussiness in babies, a post from the Cleveland Clinic said. The supplement is not regulated by the FDA and is sold under several different brand names, with the most common ingredients being baking soda, ginger and other flavorings.
“Because herbal remedies aren’t subject to the same level of government oversight as food or medicine, there’s no way to be sure that the gripe water you buy for your baby meets basic quality or safety standards,” the post said. “The ingredients and manufacturing process are at the discretion of the company making it.”
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