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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 and caregivers 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 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 affected lot is marked 25122bw; parents and caregivers are advised to stop using it because the company says exposure may pose health risks, particularly depending on the amount consumed and the user’s age and body weight.
The recall covers 4-fluid-ounce bottles with a best-before date of December 2028. The product is sold in an amber bottle inside a blue cardboard box, with an oral syringe included. The company says the lot number appears on the bottom of the box and on a side panel of the bottle. Consumers should check both the product name and lot number, rather than relying on the brand name alone, because the notice identifies only one lot.
According to the recall notice posted by the U.S. Food and Drug Administration, testing found approximately 8.3% ethanol, 0.35% methanol and 0.48% isopropanol. None of the three substances was declared on the product label. The notice says the potential risk depends on how much is consumed and on the age and body weight of the person using the product.
Pacific Health Sciences says the affected product went to Secrets of Tea for further distribution, including through online retailers such as the Secrets of Tea website and Amazon. The company asks consumers, parents and caregivers to stop using any product from lot 25122bw and either discard it or return it to the place of purchase for a refund. The company reports that it has received no adverse-event reports associated with this lot as of the announcement.
Risks for Infants and Caregivers
The recall matters because the product is marketed as a baby sleep gripe water dietary supplement, while testing identified alcohols that were not disclosed on its label. Caregivers may use the product without knowing those substances are present, and the notice says risk can vary with both the amount taken and the user’s age and body weight. That makes identifying the specific lot important for households that have the product.
The company’s hazard statement says exposure to amounts recommended on the packaging can cause drowsiness, incoordination, behavioral changes, nausea, vomiting and abdominal pain. It says larger exposures may raise the risk of respiratory depression and other serious health consequences. The notice also says ethanol exposure in infants has been linked to long-term developmental consequences. These are stated potential effects; the recall notice does not say that anyone has experienced them from this lot.
The issue also highlights why an undeclared ingredient can matter even when a product is used as directed: the label does not give caregivers a way to account for those substances when deciding whether or how much to administer. The recommended response in the notice is to stop using the affected lot, not to estimate a safe amount.
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How the Recall Was Announced
The FDA page identifies this as a company announcement and says the agency posts company recall, market-withdrawal and safety-alert announcements as a public service. It also states that posting does not mean the FDA endorses the product or the company. The recall is described as voluntary and conducted with the FDA’s knowledge.
Pacific Health Sciences dated its announcement October 6, 2026; the FDA published the notice on October 7. The company said the updated announcement was intended to clarify the hazard described in its earlier release. The stated reason for recall is the presence of ethanol, methanol and isopropanol that were not listed on the label, based on FDA testing of this lot.
The notice names Secrets of Tea and online retailers as distribution channels, but does not list every seller or give a complete count of bottles distributed. It identifies lot 25122bw and a December 2028 best-before date to help consumers distinguish the recalled product from other products or lots.
““FDA testing of this lot identified ethanol, methanol, and isopropanol that were not declared on the product label.””
— Pacific Health Sciences, in the company announcement posted by the FDA
Distribution and Exposure Details
The notice does not state how many bottles were distributed, when sales began or whether all affected units have been located or removed from sale. It names Secrets of Tea and online channels, including Amazon, but does not provide a full retailer list or say whether every seller has completed its response.
The company reports no adverse-event reports associated with the lot as of its announcement. That statement does not establish whether anyone used the product without reporting a reaction. The notice also does not give individual exposure details or identify a confirmed case linked to the recalled product. The reported ingredient concentrations are approximate, and the notice cautions that risk depends on amount consumed, age and body weight.
Check the Lot and Seek Help
Consumers and caregivers should check the package for lot number 25122bw and stop using the product if it matches. The company says affected bottles may be discarded or returned to the place of purchase for a refund. The notice does not provide a separate deadline for returns.
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, with phone support Monday through Thursday, 9:30 a.m. to 5 p.m. Pacific Time. Reactions may also be reported to the FDA’s MedWatch program online or by mail or fax using its reporting forms.
Further information about retailer actions, the number of affected units and any newly reported reactions was not included in the October 7 notice. Consumers can use the company and FDA contact channels to ask questions or submit reports as the recall proceeds.
Key Questions
Which Babies’ Magic Tea product is included in the recall?
The recall covers Babies’ Magic Tea brand Baby Sleep Gripe Water in 4-fluid-ounce bottles, but only lot 25122bw, with a best-before date of December 2028.
Why was the lot recalled?
The FDA says 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 product label.
What should I do if I have the recalled product?
Stop using any product from lot 25122bw. Pacific Health Sciences says consumers may discard it or return it to the place of purchase for a refund.
What symptoms does the recall notice describe?
The notice says exposure at amounts recommended on the packaging may cause drowsiness, incoordination, behavioral changes, nausea, vomiting or abdominal pain. It says higher exposure may increase the risk of respiratory depression and other serious effects. Anyone experiencing symptoms after use should seek medical attention.
Have adverse events been reported?
Pacific Health Sciences says it had received no reports of adverse events associated with this lot as of its announcement. The notice does not establish whether there have been unreported reactions.
Source: primary
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