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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. The affected lot is 25122bw, with a best-before date of December 2028; consumers are told to stop using it 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 testing by the U.S. Food and Drug Administration found undeclared ethanol, methanol and isopropanol in the dietary supplement. The affected product is lot 25122bw, best before December 2028; parents and caregivers are being told to stop using it.
The recalled product is sold in a 4-fluid-ounce 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 company’s announcement says FDA testing measured approximately 8.3% ethanol, 0.35% methanol and 0.48% isopropanol. None of the three substances was declared on the product label.
The company’s notice says the potential risk depends on how much is consumed and the user’s age and body weight. It describes possible effects at amounts recommended on the packaging as drowsiness, incoordination, behavioral changes, nausea, vomiting and abdominal pain. Higher exposure may raise the risk of respiratory depression and other serious health consequences. These are hazards described in the recall notice, not a statement that any specific consumer has experienced them.
Pacific Health Sciences says the product was distributed to Secrets of Tea for further distribution through online sellers, including the Secrets of Tea website and Amazon. The company reports it has received no adverse-event reports associated with this lot to date. The recall is voluntary and, according to the announcement posted by the FDA, is being conducted with the agency’s knowledge.
Risks for Infants and Caregivers
The recall concerns a product marketed for baby sleep and gripe-water use, making the undeclared ingredients especially relevant to parents and caregivers who may have given it to an infant. The company’s notice says the risks associated with these alcohols can vary according to the amount consumed and a person’s age and body weight. It also warns that exposure to amounts recommended on the package may cause symptoms, while higher amounts may lead to more serious effects.
The notice does not say that all bottles or lots are affected. It identifies one specific lot, 25122bw. Checking the lot number can help consumers distinguish the recalled product from items that are not named in this announcement. The distribution information also points consumers toward online purchases, including Amazon and the Secrets of Tea website, though the notice does not give sales totals or a list of affected orders.
For families, the practical step is to stop using the identified lot rather than rely on the absence of reported reactions as proof of safety. The company’s report of no adverse events is a status update, not evidence that exposure cannot cause harm. Anyone with concerns about a possible exposure or symptoms can contact a health professional; the recall notice advises seeking medical attention if symptoms occur after use.
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Details of the Recall Notice
The FDA page labels this as a company announcement and explains that it posts company recall notices as a public service; the agency says it does not endorse the product or company. The company’s announcement is dated October 6, 2026, and the FDA page lists a publication date of October 7. The company described the notice as an update to its earlier press release, saying it was clarifying the hazard associated with use or consumption.
This is a dietary supplement recall, not a notice covering every Babies’ Magic Tea product. The recall information identifies Baby Sleep Gripe Water in the 4-ounce package and names lot 25122bw, with a best-before date of 12/2028. It says FDA testing detected the undeclared substances in that lot. The supplied notice does not identify the source of the alcohols or explain how they entered the product.
Distribution is described as passing through Secrets of Tea and online retailers, including Amazon. The announcement does not specify the dates of sale, the number of bottles distributed, which individual listings or orders were affected, or whether the product was sold through other channels. Those details are not established by the information in the posted notice.
““Pacific Health Sciences is voluntarily recalling one lot of Babies’ Magic Tea brand Baby Sleep Gripe Water dietary supplement.””
— Pacific Health Sciences, in its recall announcement
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What the Notice Does Not Establish
The recall notice does not say how many bottles were distributed or sold, when sales took place, or how many consumers may have purchased the affected lot. It also does not identify the source of the ethanol, methanol and isopropanol, explain why they were present, or describe any manufacturing or testing changes beyond the reported FDA testing result.
The company says it has received no adverse-event reports associated with lot 25122bw, but the announcement does not provide details about how that information was collected or whether consumers have reported exposures without symptoms. It also does not give results for other lots. The stated findings apply to the lot identified in the recall notice; the available information does not establish that other lots contain the same substances.
The FDA page says the agency is posting the company’s announcement as a public service and does not endorse the product or company. The notice states the recall is being conducted with FDA knowledge, but it does not describe an FDA enforcement action or provide a separate agency assessment of the company’s investigation.
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Steps for Buyers and Caregivers
Consumers, parents and caregivers should stop using any product from lot 25122bw. The company says they may discard it or return it to the place of purchase for a refund. Check the lot number on the bottom of the box or the side panel of the bottle, rather than relying only on the brand name or package appearance.
Anyone who experiences symptoms after using the product should seek medical attention and contact Pacific Health Sciences. The company lists its phone number as 310-457-1775 and email as myorder@pacifichealth.com, with listed service hours Monday through Thursday, 9:30 a.m. to 5 p.m. Pacific Time. The notice also directs consumers to report adverse reactions through the FDA’s MedWatch program online, by mail or by fax.
The company’s notice does not provide a timetable for any further findings or updates. Consumers seeking a refund or information about a purchase can contact the seller or Pacific Health Sciences using the contact details in the announcement. Further information about the cause of contamination, the distribution volume and any investigation findings remains pending in the material provided.
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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 amber bottle inside a blue box, but only lot 25122bw, best before December 2028.
Why was this lot recalled?
According to the company’s notice, FDA testing found ethanol, methanol and isopropanol that were not declared on the label. The notice reports measured levels of approximately 8.3%, 0.35% and 0.48%, respectively.
What should I do if I have the recalled product?
Stop using lot 25122bw. The company says consumers may discard it or return it to the place of purchase for a refund. Check the lot number printed on the box or bottle.
Have any adverse events been reported?
Pacific Health Sciences says it has received no reports of adverse events associated with this lot to date. The company’s statement does not mean that exposure is risk-free; the notice describes possible effects and advises medical attention if symptoms occur after use.
Where can consumers report a reaction or ask questions?
The company lists 310-457-1775 and myorder@pacifichealth.com for questions or reaction reports. Consumers can also report adverse reactions through the FDA’s MedWatch program, as described in the recall notice.
Source: primary
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