WASHINGTON, DC — A baby dietary supplement sold online and marketed to help infants sleep has been recalled after U.S. Food and Drug Administration testing found undeclared alcohol in the product. The agency said the issue involves one lot of Babies’ Magic Tea brand Baby Sleep Gripe Water, which was distributed by Pacific Health Sciences.
The recalled product comes in a 4-ounce amber bottle inside a blue cardboard box and includes an oral syringe. Officials say parents and caregivers should stop using the product right away. The FDA said the lot was sold through Secrets of Tea’s website and on Amazon.
Testing found ethanol, methanol and isopropanol that were not on the label
The FDA said laboratory testing found the recalled gripe water contained approximately 8.3% ethanol, 0.35% methanol and 0.48% isopropanol. None of those ingredients were listed on the product label.
In a recall notice posted Oct. 7, the agency said the undeclared substances may pose a risk depending on how much is consumed and the age and body weight of the person using it. The FDA specifically warned that exposure could be especially concerning for babies and infants.
According to the agency, infant ethanol exposure has been linked to long-term developmental consequences. The notice also said higher levels of exposure can increase the risk of respiratory depression and other serious adverse health effects.
Recalled lot carries a best-before date of December 2028
The recall applies to Lot 25122bw, which has a best-before date of December 2028. Pacific Health Sciences voluntarily recalled the lot after the FDA’s findings, according to the agency.
The product was sold as a dietary supplement and advertised as a way to help babies with “better sleep.” The FDA’s notice focuses only on the specific lot identified in the recall and does not indicate that every version of the product is included.
Parents who have the product should check the lot number and best-before date before deciding what to do next. The recall notice says consumers should either discard the product or return it for a refund.
No illnesses have been reported for the affected lot
So far, Pacific Health Sciences has not received reports of health problems linked to the recalled lot, the FDA said. Even so, the agency is urging families not to keep using the product while the recall is in effect.
If a child or infant shows symptoms after using the supplement, the FDA said caregivers should seek medical attention and contact Pacific Health Sciences. The warning is aimed at anyone who may have given the product to a baby and is concerned about possible exposure.
The agency’s advice is meant to reduce the chance of continued use while the product remains in homes, especially since the risk depends on the amount consumed and the child’s size.
How parents can identify the bottle and packaging
The recalled product is described as a 4-ounce amber-colored bottle packaged in a blue cardboard box and accompanied by an oral syringe. The packaging details are important because the supplement was sold online, where products can be harder to distinguish from similar items.
Parents and caregivers are being told to review the bottle’s label for Lot 25122bw and the December 2028 best-before date. Anyone who finds that lot should stop use immediately rather than continue giving it to a baby.
The FDA said the product was distributed to Secrets of Tea for sale on its website and through Amazon. That distribution path makes the recall relevant to families who may have purchased the supplement without seeing it in a traditional store.
FDA warning highlights the risks of hidden ingredients in infant products
The recall underscores why ingredient accuracy matters in products intended for babies. The FDA said undeclared alcohol can pose a risk that depends on dose, age and body weight, which is especially important for infants.
Because the product was promoted for sleep support, parents may have used it with the expectation that it was a routine baby supplement. The agency’s notice makes clear that the discovered ingredients were not part of the label disclosure and should not be assumed to be harmless.
For families who bought the product, the immediate steps are simple: stop using it, discard it or return it for a refund, and get medical help if symptoms appear after exposure.
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