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Pacific Health Sciences is voluntarily recalling one lot of Babies’ Magic Tea Baby Sleep Gripe Water after FDA testing found undeclared ethanol, methanol and isopropanol. The company says it has received no reports of adverse events associated with the lot; consumers and caregivers are instructed to stop using it and discard or return it for a refund.

Pacific Health Sciences is voluntarily recalling one lot of Babies’ Magic Tea brand Baby Sleep Gripe Water after U.S. Food and Drug Administration testing found undeclared ethanol, methanol and isopropanol in the dietary supplement. The affected product is lot 25122bw, marked best before December 2028; consumers and caregivers are advised to stop using it.

The recall covers 4-fluid-ounce (about 118-milliliter) bottles of Babies’ Magic Tea Baby Sleep Gripe Water. The product comes in an amber bottle 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. The announcement identifies no other lots as affected.

According to the company’s announcement posted by the FDA, testing of this lot measured approximately 8.3% ethanol, 0.35% methanol and 0.48% isopropanol. None of the three substances was declared on the label. The announcement says the possible risk depends on the amount consumed and the user’s age and body weight; it does not provide a specific estimate of exposure or describe a confirmed injury.

Pacific Health Sciences said the affected product was distributed to Secrets of Tea for subsequent sale through online retailers, including Secrets of Tea’s website and Amazon. The company directs consumers, parents and caregivers to discard affected bottles or return them to the place of purchase for a refund. It says it has received no reports of adverse events associated with this lot to date.

At a glance
announcementWhen: Company announcement dated October 6, 2…
The developmentPacific Health Sciences announced a voluntary recall of one lot of Babies’ Magic Tea Baby Sleep Gripe Water after FDA testing detected three alcohols absent from the product label.

Identifying the Recalled Baby Supplement

The recall concerns a product intended for infants, so families may need to check bottles already in their homes rather than relying only on the product name. The notice applies to a specific lot number, 25122bw, and says to stop using that lot because testing found substances that are not listed on its label. Checking both the bottle and its box can help identify whether a product matches the recall.

The announcement does not say that anyone has been harmed, and the company reports no adverse-event reports tied to the lot. At the same time, the identified substances and their measured levels make the recall relevant to anyone who may have given the product to a child. The stated risk depends on how much was consumed and the person’s age and body weight, so the notice does not support a single risk estimate for every user.

For consumers, the immediate action is straightforward: do not give the affected lot to a child, and discard it or seek a refund from the place of purchase. Anyone who experiences symptoms after use should seek medical attention, according to the company’s notice. Questions and possible reactions can also be reported to Pacific Health Sciences or through the FDA’s MedWatch program.

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What the FDA Recall Notice Says

The FDA page labels this as a company announcement and explains that it posts company recall notices as a public service. The agency says posting an announcement does not mean it endorses the product or the company. The company dated its announcement October 6, 2026, and the FDA published it the following day.

Pacific Health Sciences describes the action as a voluntary recall conducted with the FDA’s knowledge. The stated reason is the presence of ethanol, methanol and isopropanol detected through FDA testing, despite the substances not appearing on the product label. The notice provides measured concentrations for the tested lot but does not give additional testing details, including when or how samples were collected.

The distribution information names Secrets of Tea as the recipient for subsequent distribution and lists its website and Amazon as online sales channels. The notice does not provide sales dates, the number of bottles distributed, or a complete list of individual sellers. Consumers who bought the product online can use the lot number and best-before date to compare their bottle with the recall details.

“To date, Pacific Health Sciences has received no reports of adverse events associated with this lot.”

— Pacific Health Sciences, in the company announcement posted by the FDA

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Exposure and Distribution Details

The notice does not state how many bottles were distributed or sold, when sales began or ended, or whether all online listings have been removed. It names Secrets of Tea, its website and Amazon, but does not provide a full seller-by-seller list. It is also unclear how many consumers may have purchased or used the recalled lot.

The company reports no adverse-event reports associated with the lot as of its announcement, but the notice does not give a follow-up period or independently establish whether any individual experienced effects. The FDA page lists concentrations found in testing, while leaving details about the sampling and testing process unspecified. No details are provided about how the substances came to be present in the product.

The notice also does not identify additional affected lots or say whether other products from the company were tested. Its stated recall scope is one lot, 25122bw; consumers should not assume from this notice alone that other lots are affected or that they have been cleared.

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Steps for Buyers and Caregivers

Consumers should check the bottle and box for lot 25122bw and a best-before date of 12/2028. If the lot matches, the company says to stop using the product and either discard it or return it to the place of purchase for a refund. The notice does not specify a return deadline or describe a separate refund process for online orders, so buyers may need to contact the retailer.

Anyone who experiences symptoms after using the product should seek medical attention and contact Pacific Health Sciences, according to the recall notice. The company lists 310-457-1775 and myorder@pacifichealth.com for questions or reaction reports; its listed hours are Monday through Thursday, 9:30 a.m. to 5 p.m. Pacific Time. Reactions may also be reported to the FDA through its MedWatch online reporting program or by mail or fax using the agency’s forms.

The company’s announcement does not set out a further update schedule. Consumers can monitor the FDA recall page and contact the retailer or Pacific Health Sciences for information about returns, refunds or any additional recall notices.

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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 12/2028.

Why was this lot recalled?

The company says FDA testing found approximately 8.3% ethanol, 0.35% methanol and 0.48% isopropanol in the lot. The substances were not declared on the label.

What should I do if I have the affected product?

Stop using lot 25122bw. The company advises consumers and caregivers to discard the product or return it to the place of purchase for a refund.

Have adverse events been reported?

Pacific Health Sciences said it had received no reports of adverse events associated with this lot as of its announcement. The notice does not provide further information about possible individual exposures.

How can I contact the company or report a reaction?

Pacific Health Sciences 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. The notice also directs consumers to the FDA’s MedWatch adverse-event reporting program.

Source: primary

This article is for informational purposes only and is not medical advice. Always consult a qualified healthcare professional about your specific situation.
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