A Baby Sleep Remedy Was Marketed for ‘Better Sleep,’ Then FDA Testing Found Three Alcohols Missing From the Label

A Baby Sleep Remedy Was Marketed for ‘Better Sleep,’ Then FDA Testing Found Three Alcohols Missing From the Label

Pacific Health Sciences announced on October 6, 2026, that it was voluntarily recalling one lot of Babies’ Magic Tea brand Baby Sleep Gripe Water after testing identified three alcohols that were not disclosed on the label. The Food and Drug Administration (FDA) published the company’s announcement on October 7, and the issue was subsequently covered in The New York Post’s October 12 report. The findings raised concerns about a product intended for infants because its ingredients included substances that can pose health risks depending on exposure.

The recall is specifically identified as a voluntary action involving one lot rather than a blanket recall of every Babies’ Magic Tea product. Pacific Health Sciences is the company named in the announcement, which was published through the FDA’s official recall notice. That distinction is important for parents checking products already purchased or stored at home.

The Packaging Helps Parents Identify the Affected Product

The recalled item is Babies’ Magic Tea brand Baby Sleep Gripe Water, sold in a four-fluid-ounce, approximately 118-milliliter, amber bottle. The bottle comes inside a blue cardboard box, and the package includes an oral syringe for administering the liquid. These identifying details are important because the recall applies to a specific batch, not simply to anything carrying the brand name.

The lot number appears on the bottom of the box and on a side panel of the bottle, while the listed best-before date is December 2028. In its October 9 report, ABC News also described these identifying features and confirmed that lot 25122bw is the affected batch. Parents should compare their product’s printed details against the recall information rather than relying on the appearance of the bottle alone.

The Product Was Marketed for ‘Better Sleep’

Babies’ Magic Tea Baby Sleep Gripe Water was presented as a product intended to help infants sleep better and address digestive complaints. Fox Business’s coverage of the recall reported that the packaging promoted it for better sleep and relief from gas, bloating, constipation and acid reflux. Those advertised uses help explain why caregivers might consider the product when looking for ways to comfort a baby.

However, marketing claims are not the same as independently established medical benefits. The recall announcement focuses on the results of product testing and the potential risks associated with the substances detected, rather than determining whether the product delivers its advertised benefits. The immediate concern is that the three alcohols found during testing were not disclosed to consumers on the label.

FDA Testing Found Three Undeclared Alcohols

Testing of the affected lot identified ethanol, methanol and isopropanol, all of which were absent from the product’s ingredient labeling. The measured concentrations were approximately 8.3% ethanol, 0.35% methanol and 0.48% isopropanol. These figures are the central findings behind the recall and explain why the company advised consumers to stop using the affected batch.

The presence of multiple undisclosed substances is a significant labeling and safety concern for a product intended for infants. Parents ordinarily rely on packaging to understand what they are giving their children and to follow the manufacturer’s administration instructions. In this case, the testing revealed that the listed ingredients did not disclose all the substances found in the tested lot.

Ethanol Was the Highest Measured Concentration

Of the three alcohols identified, ethanol had the highest measured concentration, at approximately 8.3%. The company warned that infant exposure to ethanol has been linked to long-term developmental consequences. Its presence in a product intended for babies therefore raises concerns beyond whether the liquid might cause temporary discomfort.

The concentration detected in the product does not, by itself, establish how much ethanol any particular child may have consumed. That would depend on whether the product was administered, how much was given and the circumstances of the exposure. The recall notice identifies a potential hazard rather than providing an individualized assessment of risk for every baby who might have received the liquid.

Methanol and Isopropanol Were Also Detected

The testing also identified methanol and isopropanol at approximately 0.35% and 0.48%, respectively. Neither substance was disclosed on the label, just like the ethanol found in the same batch. Their presence means the concern cannot be reduced to a single unexpected ingredient.

According to the company’s announcement, organic alcohols such as these can interfere with normal functioning of the central nervous system. The public notice does not explain how the compounds entered the affected product or identify a confirmed cause for their presence. Without further verified information, attributing the findings to a particular supplier, ingredient or manufacturing process would be speculation.

The Potential Risk Depends on the Amount Consumed

The recall notice emphasizes that the potential danger depends partly on how much of the product is consumed, as well as the user’s age and body weight. These factors matter when evaluating exposure in infants, whose size differs substantially from that of older children and adults. The percentages measured in the bottle do not establish that every child faced the same level of risk.

The announcement also does not say that every bottle from the affected lot necessarily resulted in a harmful exposure. Finding potentially hazardous substances in a product and documenting an injury following its use are two different things. Nevertheless, the uncertainty about individual exposure does not change the company’s instruction to stop using the recalled batch.

The Warning Includes Several Possible Symptoms

The company’s notice lists drowsiness, loss of coordination, behavioral changes, nausea, vomiting and abdominal pain among the possible effects associated with exposure at amounts recommended on the packaging. These warnings describe potential consequences, not a list of symptoms confirmed in children involved in this particular recall. They are intended to explain why the substances’ presence matters even when an adverse event has not been reported.

The company also warned that exposure to higher amounts could increase the risk of respiratory depression and other serious adverse health consequences. That warning makes it especially important not to interpret the product’s original dosing instructions as assurance that the recalled batch is safe. The recall directs anyone who experiences symptoms after using the product to seek medical attention.

No Adverse Events Had Been Reported in Connection With the Lot

Pacific Health Sciences stated in its recall announcement that it had not received reports of adverse events associated with the affected lot at the time of the notice. PEOPLE’s October 8 coverage likewise reported that no illnesses had been reported following the discovery. That information provides important context about what was known publicly when the recall was announced.

The absence of reported injuries does not establish that the product was harmless or invalidate the laboratory findings. Instead, it means the company had reported no associated adverse events despite the discovery of undeclared alcohols. The recall was prompted by the contents detected in the product, rather than by a publicly reported case of a specific infant becoming ill.

The Product Was Distributed Through Online Retailers

According to the recall notice, the affected product was distributed to Secrets of Tea for subsequent sale through online retailers, including the Secrets of Tea website and Amazon. This distribution information gives consumers a practical starting point when checking where they purchased the product. However, the notice does not provide a total number of bottles sold or a complete breakdown of customer purchases.

Online purchases can also make it harder for caregivers to remember the exact batch associated with an item they bought earlier. Some consumers may still have the original cardboard box, while others may have only the bottle available for inspection. Checking the lot identifier is therefore more reliable than assuming a product is unaffected because the purchase occurred some time ago.

Parents and Caregivers Are Being Told to Stop Using the Product

The company’s instructions are straightforward: anyone possessing the recalled lot, identified as 25122bw, should stop using it immediately. Consumers are advised to discard the product or return it to the place of purchase for a refund. The recommendation applies to the identified lot regardless of whether the product has already been opened.

Parents should use the printed code to determine whether their bottle matches the recall details. A matching lot number is the relevant identifier, rather than the brand name alone or the product’s advertised purpose. Caregivers should not continue administering a bottle from the affected lot while deciding whether its contents have caused any symptoms.

Consumers Have a Way to Contact the Company About Exposure

The recall announcement instructs anyone experiencing symptoms after using the product to seek medical attention and contact Pacific Health Sciences. The company lists its telephone number as 310-457-1775 and its email address as [email protected]. The listed contact hours are Monday through Thursday, from 9:30 a.m. to 5 p.m. Pacific Time.

The notice also explains that consumers may report adverse reactions through the FDA’s MedWatch program. If a baby may have received the product, a healthcare professional can help assess the situation using the child’s individual circumstances and any symptoms present. Urgent symptoms should be evaluated promptly rather than waiting for a response from the manufacturer.

The Recall Raises a Broader Question About Gripe Water

Gripe water is sold in different formulations, and families sometimes use it while trying to manage infant gas, fussiness or colic. The American Academy of Pediatrics explains in its guidance on responding to a baby’s cries that research has not shown gripe water products to work for these complaints. That context is separate from the current recall, but it is relevant to caregivers weighing the potential benefits of products intended to soothe infants.

For persistent crying or digestive concerns, pediatric guidance recommends discussing the baby’s symptoms with a healthcare professional and considering appropriate feeding and soothing strategies. The findings involving Babies’ Magic Tea do not establish that every gripe-water product contains the same substances or presents the same risk. They do, however, underscore the importance of checking safety notices, reading labels carefully and taking a recall seriously when testing identifies ingredients that consumers were not told about.

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