TL;DR
Pacific Health Sciences is recalling one lot of Babies’ Magic Tea Baby Sleep Gripe Water after FDA testing found undeclared ethanol, methanol and isopropanol. Consumers should stop using lot 25122bw and discard it or return it for a refund; the company says it has received no reports of adverse events tied to the lot.
Pacific Health Sciences is 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 company said consumers should stop using lot 25122bw, which was sold in 4-fluid-ounce bottles, and discard it or return it to the place of purchase for a refund.
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The recalled product is labeled Babies’ Magic Tea Baby Sleep Gripe Water, with a best-before date of December 2028. It comes in an amber bottle inside a blue cardboard box; the lot number appears on the bottom of the box and on a side panel of the bottle. An oral syringe is included. The recall applies to lot 25122bw, not all products sold under the brand.
According to the company’s announcement posted by the U.S. Food and Drug Administration, FDA testing found approximately 8.3% ethanol, 0.35% methanol and 0.48% isopropanol. The substances were not declared on the label. Pacific Health Sciences said the potential risk depends on the amount consumed and the user’s age and body weight. The notice 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 effects.
The product was distributed to Secrets of Tea for further sale through online retailers, including Secrets of Tea’s website and Amazon, the company said. Consumers, parents and caregivers are advised to stop using the affected lot and either discard it or return it to the retailer for a refund. Anyone who develops symptoms after using the product should seek medical attention and contact the company.
Why the Lot Number Matters
The recall concerns a product marketed for babies and young children, for whom exposure risk may vary with age, body weight and how much is taken. The notice says the listed alcohols can affect normal central nervous system function. It also warns that infant ethanol exposure has been linked to possible long-term developmental consequences. These statements describe potential hazards; the announcement does not report confirmed injuries associated with this lot.
For families, the immediate practical step is to check the lot number on the package, rather than relying only on the product name or best-before date. The company says it has received no reports of adverse events associated with lot 25122bw as of the announcement. That report status does not change the recall instruction to stop using the affected product.
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How the Recall Was Announced
The company dated its announcement October 6, 2026; the FDA published it the following day as a company announcement. The FDA page says it posts company recall, market withdrawal and safety announcements as a public service and does not endorse the product or company. The notice states that the voluntary recall is being conducted with the FDA’s knowledge.
Pacific Health Sciences described the October 6 release as an update intended to explain the hazard more clearly. Its announcement identifies a single lot and names the testing results and affected distribution channels. The supplied notice does not say when the lot was first sold, how many bottles were distributed, or whether every retailer listing has been removed.
““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
Questions About Exposure and Sales
The announcement does not provide the number of bottles distributed, the dates they were available for purchase, or whether all affected stock has been removed from online and retail channels. It also does not identify how the undeclared substances entered the product or describe any investigation into the cause.
No adverse-event reports tied to this lot had been received by the company as of its notice, but the announcement does not state how many consumers may have used the product. The stated concentrations are approximate, and the notice does not provide individual exposure assessments. The actual risk for a particular child would depend on the amount consumed and other factors identified by the company, including age and body weight.
Steps for Families and Retailers
Caregivers should check the package for lot 25122bw and stop using it if the lot matches. The company says the product can be discarded or returned to the place of purchase for a refund. Anyone with symptoms after use should seek medical attention. For questions or to report a reaction, Pacific Health Sciences lists 310-457-1775 and myorder@pacifichealth.com; its stated phone hours are Monday through Thursday, 9:30 a.m. to 5 p.m. Pacific Time.
Consumers can also report adverse reactions to the FDA’s MedWatch program online or by mail or fax. The company has not provided a date for a further update, and the notice does not specify a deadline for returns. Retailers and online sellers may provide further information about affected inventory and refund arrangements.
Key Questions
Which product is included in the recall?
The recall covers Babies’ Magic Tea brand Baby Sleep Gripe Water in a 4-fluid-ounce bottle, but only lot 25122bw. The stated best-before date is December 2028.
Why was the product recalled?
FDA testing found approximately 8.3% ethanol, 0.35% methanol and 0.48% isopropanol in the lot. The company said these substances were not listed on the product label.
What should caregivers do with the affected product?
Stop using the product if its lot number is 25122bw. Pacific Health Sciences advises consumers to discard it 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 company advises anyone experiencing symptoms after use to seek medical attention and contact it.
Where can consumers ask questions or report a reaction?
Pacific Health Sciences lists 310-457-1775 and myorder@pacifichealth.com for questions or reaction reports. Reactions may also be submitted through the FDA’s MedWatch program.
Source: primary
