Washington, D.C. — Parents are being urged to check their baby supplement bottles after a product marketed to help infants sleep was voluntarily recalled following the discovery of three undeclared alcohol compounds, according to a company announcement published on the U.S. Food and Drug Administration’s website.
The recall involves Babies’ Magic Tea brand Baby Sleep Gripe Water, distributed by Pacific Health Sciences. On Tuesday, October 6, the FDA announced that one lot of the dietary supplement had been recalled after testing identified ethanol, methanol and isopropanol that were not listed on the product label.
The discovery has raised concerns about potential health risks, particularly because the product is intended for use by infants. The FDA warned that exposure to these substances can affect the central nervous system and may cause adverse effects depending on the amount consumed and the child’s age and body weight.
Which Baby Supplement Has Been Recalled?
The recall is limited to one lot of Babies’ Magic Tea Baby Sleep Gripe Water, identified by lot number 25122bw.
The affected product comes in a 4-ounce (approximately 118-milliliter) amber bottle packaged inside a blue cardboard box. According to the FDA, the lot number is printed on the bottom of the box and on a side panel of the bottle. An oral syringe is also included in the packaging.
Parents and caregivers should carefully check the product name and lot number to determine whether they have the recalled supplement.
The company said the recall followed FDA testing that identified three alcohol compounds that were not disclosed on the product label.
FDA Testing Found Three Undeclared Compounds
The FDA’s testing identified ethanol, methanol and isopropanol in the recalled lot. The company’s announcement stated:
“FDA testing of this lot identified ethanol, methanol, and isopropanol that were not declared on the product label,”
The statement continued:
“Measured levels were approximately 8.3% ethanol, 0.35% methanol, and 0.48% isopropanol. These substances were not listed on the label. Their presence may pose a risk depending on the amount consumed and the age and body weight of the person using the product.”
The findings are particularly concerning because the product is intended for babies, whose smaller body size can make them more vulnerable to the effects of certain substances.
The presence of undeclared ingredients also means that caregivers may not have been aware of the potential exposure when administering the supplement according to its packaging instructions.
What Health Risks Does the FDA Warn About?
The FDA warned that organic alcohols, including ethanol, methanol and isopropanol, can interfere with normal central nervous system function.
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According to the agency, exposure to amounts recommended on the product’s packaging can cause drowsiness, incoordination, behavioral changes, nausea, vomiting and abdominal pain.
The FDA also cautioned that exposure to higher amounts could increase the risk of respiratory depression and other serious adverse health consequences.
The potential effects depend on several factors, including how much of the supplement is consumed and the age and body weight of the person exposed.
Because the product is intended for infants, parents and caregivers should take the recall seriously and avoid assuming that the supplement is safe simply because it was marketed for babies.
Where Was the Recalled Product Sold?
The affected supplements were sold online through Secrets of Tea’s website and Amazon, according to the recall announcement.
Consumers who purchased the product online should check their bottles and packaging for lot number 25122bw. The recall applies to that specific lot, rather than automatically covering every product sold under the brand. Parents who discover that they have the affected product should stop using it and follow the company’s recall instructions.
Anyone concerned that a baby may have consumed the recalled supplement should contact a healthcare professional or poison control service for guidance. If an infant develops serious symptoms, emergency medical assistance should be sought.
No Illnesses Have Been Reported So Far
As of the recall announcement, no illnesses had been reported in connection with the affected lot.
However, the absence of reported illnesses does not eliminate the potential risk identified through FDA testing. The agency’s warning highlights the importance of checking the product details and taking appropriate precautions.
For parents and caregivers, the key step is to verify the lot number before using any remaining Baby Sleep Gripe Water and to avoid giving the recalled product to an infant.
Have you purchased Babies’ Magic Tea Baby Sleep Gripe Water recently? Check the lot number on your packaging and share this recall information with other parents and caregivers who may need to know about it.
