Photo: FDA
A nationally sold baby supplement has been voluntarily recalled due to undeclared alcohols found in the product. Pacific Health Sciences announced this week it is recalling one lot of its Babies' Magic Tea brand Baby Sleep Gripe Water after U.S. Food and Drug Administration (FDA) testing revealed the presence of ethanol, methanol, and isopropanol, none of which were listed on the label.
According to the FDA recall notice, the affected lot—number 25122bw—was sold in 4-ounce bottles inside blue cardboard boxes and has a best-by date of December 2028. The measured levels in the recalled product were about 8.3% ethanol, 0.35% methanol, and 0.48% isopropanol. For comparison, federal guidelines allow no more than 0.5% ethanol as an inactive ingredient in over-the-counter products for children under six years old.
The FDA warned, "Their presence may pose a risk depending on the amount consumed and the age and body weight of the person using the product." Short-term symptoms from exposure can include drowsiness, behavioral changes, nausea, and vomiting, while higher exposures could cause more serious health issues such as respiratory depression. Health authorities also noted that long-term exposure to ethanol in infants can have developmental effects.
The gripe water was distributed by Pacific Health Sciences through online retailers, including the company’s own website and Amazon. As of now, there have been no reports of adverse events linked to the recalled lot.
Parents and caregivers are advised to stop using the product immediately and either discard it or return it to the place of purchase for a refund. Pacific Health Sciences can be reached at 310-457-1775 or myorder@pacifichealth.com for questions or concerns. Anyone experiencing symptoms after using the product should seek medical attention.