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Pacific Health Sciences is voluntarily recalling lot 25122bw of Babies’ Magic Tea Baby Sleep Gripe Water after FDA testing found undeclared ethanol, methanol and isopropanol. Consumers should stop using the affected lot and discard it or return it for a refund. The company says it has received no reports of adverse events associated with the lot.
Pacific Health Sciences is voluntarily recalling one lot of Babies’ Magic Tea brand Baby Sleep Gripe Water after FDA testing found undeclared ethanol, methanol and isopropanol in the dietary supplement. The recall covers lot 25122bw, with a best-before date of December 2028; consumers and caregivers are advised to stop using it because exposure may pose health risks, particularly for infants.
The affected product is sold in a 4-fluid-ounce (about 118-milliliter) amber bottle packaged inside a blue cardboard box, with an oral syringe included. The lot number appears on the bottom of the box and on a side panel of the bottle. Pacific Health Sciences says consumers should check both the product name and lot number before deciding whether the recall applies to their bottle.
According to the FDA-posted company announcement, testing of the lot measured approximately 8.3% ethanol, 0.35% methanol and 0.48% isopropanol. The company said those substances were not declared on the product label. The announcement says the potential risk depends on the amount consumed and the user’s age and body weight.
The company says the affected product was distributed to Secrets of Tea for further sale through online retailers, including the Secrets of Tea website and Amazon. Pacific Health Sciences reported receiving no adverse-event reports associated with this lot as of its announcement. The company said the recall is being conducted with the FDA’s knowledge; the FDA’s page describes the notice as a company announcement and says posting it does not constitute FDA endorsement of the product or company.
Risks for Infants and Caregivers
The recall matters because the affected product is marketed as a baby sleep gripe water dietary supplement, while testing identified alcohols that were not disclosed on its label. Parents and caregivers may rely on product packaging when deciding what to give an infant; an undeclared ingredient means the label does not provide a complete account of what testing found in this lot.
The company announcement says ethanol, methanol and isopropanol can impair normal central nervous system function. It states that exposure to amounts recommended on the packaging may cause drowsiness, poor coordination, behavioral changes, nausea, vomiting or abdominal pain. Higher exposure may increase the risk of respiratory depression and other serious health effects. The announcement also cites potential long-term developmental consequences from ethanol exposure in infants. These are stated hazards, not reports that such outcomes have occurred among users of the recalled lot.
Because the possible effects depend on dose, age and body weight, the announcement does not set out a single exposure level that would determine risk for every child. It does give a direct precaution: stop using any product from the affected lot, and seek medical attention if symptoms occur after use.
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How the Recall Was Issued
The FDA posted the recall under its company announcement program. The company’s announcement is dated October 6, 2026, and the FDA page lists October 7, 2026, as the publication date. The notice says it updates a company press release issued on October 6 to explain the hazard more clearly.
The notice identifies a single lot rather than all Babies’ Magic Tea products. The covered product is Baby Sleep Gripe Water, lot 25122bw, best before December 2028. The provided notice does not say that other lots or other products made by Pacific Health Sciences are included in this recall.
The FDA page states that it posts company announcements as a public service and does not endorse the product or company. The recall is described as voluntary and conducted with the agency’s knowledge. The available material does not say that the FDA independently initiated the recall or issued a separate order.
““This is an update to the company’s press release, previously issued on 10/06/2026, to clearly explain the hazard associated with the consumption or use of the product.””
— Pacific Health Sciences, in the updated company announcement
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Exposure and Reports Still Unclear
The notice does not say how many bottles from lot 25122bw were distributed, how many may remain for sale or in consumers’ homes, or how many have been returned. It identifies online distribution through Secrets of Tea and Amazon, but does not provide a complete list of listings, sellers or purchase dates.
The company reports no adverse-event reports associated with the lot as of its announcement. The material provided does not give information about individual exposures, whether any consumers have sought care, or whether the company or FDA has received further reports since publication. It also does not explain how the undeclared alcohols entered the product or whether additional testing is underway.
The stated concentrations are measurements from FDA testing of the lot, but the announcement does not specify the test method or the amount of each substance in a recommended dose. The potential effect for a particular child therefore cannot be determined from the notice alone; the company says risk depends partly on quantity consumed, age and body weight.
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Steps for Affected Product Owners
Consumers, parents and caregivers should stop using any bottle marked lot 25122bw. The company advises discarding the product or returning it to the place of purchase for a refund. Check the lot number on the bottom of the blue box or the side panel of the bottle; the recall notice does not direct consumers to treat products from other lots as affected.
Anyone who experiences symptoms after using the product should seek medical attention and contact Pacific Health Sciences. The company lists 310-457-1775 and myorder@pacifichealth.com for questions or reaction reports, Monday through Thursday, 9:30 a.m. to 5 p.m. Pacific Time. Consumers may also report adverse reactions to the FDA MedWatch program online or by mail or fax using the agency’s reporting forms.
Further information may come from the company, retailers or FDA if additional distribution details or safety reports become available. The current notice does not provide a timetable for further updates, and it does not state whether the recall will expand beyond the identified lot.
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Key Questions
Which Babies’ Magic Tea product is being recalled?
The recall covers Babies’ Magic Tea brand Baby Sleep Gripe Water in a 4-fluid-ounce bottle, lot 25122bw, with a best-before date of December 2028.
Why was this lot recalled?
FDA testing found approximately 8.3% ethanol, 0.35% methanol and 0.48% isopropanol in the lot. The company says these substances were not declared on the label.
What should I do if I have the affected product?
Stop using it. Pacific Health Sciences advises consumers to discard the product or return it to the place of purchase for a refund. Check the lot number on the package or bottle.
Has the company reported any illnesses?
Pacific Health Sciences said it had received no reports of adverse events associated with the lot as of its announcement. The notice does not provide information about exposures or reports received afterward.
Who can I contact about a reaction or question?
Contact Pacific Health Sciences at 310-457-1775 or myorder@pacifichealth.com. The company says to seek medical attention if symptoms occur after use; reactions may also be reported to the FDA MedWatch program.
Source: primary
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