WASHINGTON, DC — Parents and caregivers are being told to stop using a baby dietary supplement sold online after federal testing found undeclared alcohol in the product. The U.S. Food and Drug Administration said one lot of Babies’ Magic Tea brand Baby Sleep Gripe Water was voluntarily recalled after laboratory results identified three types of alcohol not listed on the label.
The product was marketed to help babies “better sleep” and sold in 4-ounce amber-colored bottles inside a blue cardboard box with an oral syringe. The FDA said the recall covers Lot 25122bw, which has a best-before date of December 2028. Officials said the lot was distributed to Secrets of Tea for sale through its website and on Amazon.
FDA testing found ethanol, methanol and isopropanol in the recalled lot
The FDA said testing showed the recalled product contained approximately 8.3% ethanol, 0.35% methanol and 0.48% isopropanol. None of those substances were declared on the label, the agency said in its Oct. 7 recall notice.
Federal officials said the hidden ingredients could pose a risk depending on how much was consumed and the age and body weight of the person using the product. The presence of alcohol in an infant product is especially concerning because babies are far more vulnerable to small exposures than older children or adults.
The agency did not say that the recalled lot was connected to any specific illness, but it warned families to take the product seriously and stop using it right away.
Why the undeclared ingredients are considered dangerous for infants
In the recall notice, the FDA said infant ethanol exposure has been linked to long-term developmental consequences. It also said higher exposure levels can increase the risk of respiratory depression and other serious adverse health effects.
Those warnings matter because the product was intended for babies, a group that can be harmed by much smaller amounts of alcohol than older users. Even when a product appears to be a routine supplement, federal regulators treat undeclared ingredients as a major safety issue when infants are the intended users.
The FDA’s concern is not only about the amount detected, but also about the fact that caregivers would not know the product contained alcohol at all based on the label.
Pacific Health Sciences says no health complaints have been reported from the lot
Pacific Health Sciences, which the FDA identified as the recalling company, has not received reports of health impacts tied to the affected lot. Even so, the company issued the recall voluntarily after the FDA’s testing results raised safety concerns.
Voluntary recalls are common when a company works with regulators to remove a product from circulation before more people are exposed. In this case, the recalled batch was limited to one lot, but it was sold through online channels that can reach customers across the country.
The FDA said the recall notice was posted on Oct. 7. The company and federal officials are urging parents to check bottles carefully, especially if they bought the supplement through e-commerce sites.
Parents are told to discard the bottle or return it for a refund
Consumers who have Babies’ Magic Tea brand Baby Sleep Gripe Water from the recalled lot should stop using it immediately. The FDA said parents and caregivers should either discard the product or return it for a refund.
Anyone who thinks a child may have had a reaction after using the supplement should seek medical attention right away. The agency also said consumers should contact Pacific Health Sciences with concerns about the recalled product.
Because the lot was sold online, families may not have a store receipt or even remember when they ordered it. The FDA’s guidance focuses on the lot number and best-before date, which are the clearest ways to identify the recalled item.
What families should check on the bottle and box before using the supplement
The recalled product comes in a 4-ounce amber bottle packed in a blue cardboard box and includes an oral syringe. The FDA said the key identifying information is Lot 25122bw with a best-before date of December 2028.
Families who still have the package should compare those details before giving it to a baby. If the lot number matches, the product should not be used even if the bottle looks sealed or appears normal. Federal recall notices are meant to help consumers catch unsafe products before they reach the child.
Parents concerned about symptoms after use can also use the recall information to give doctors the exact product details, which can help with treatment decisions and reporting.
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