FDA Recalls Baby Sleep Aid After Finding Toxic Alcohols
Pacific Health Sciences is voluntarily recalling a batch of its Babies’ Magic Tea brand Baby Sleep Gripe Water due to the presence of undeclared toxic alcohols.
Pacific Health Sciences is voluntarily recalling Lot 25122bw of its Babies’ Magic Tea brand Baby Sleep Gripe Water after Food and Drug Administration (FDA) testing revealed the presence of toxic, unlabeled alcohols. The FDA is urging parents and caregivers to immediately stop using the product.
FDA testing detected ethanol, methanol, and isopropanol in the gripe water, none of which were listed on the product's label. Lab measurements found concentrations of approximately 8.3% ethanol, 0.35% methanol, and 0.48% isopropanol. The agency warned that exposure to these alcohols poses severe health risks to infants, including potential depression of central nervous system functions, depending on the volume consumed and the infant's age and body weight.
The FDA cautioned that infant exposure to ethanol can be linked to long-term developmental issues, such as impaired coordination and behavioral changes. Immediate physical symptoms may include drowsiness and nausea or vomiting. Ingesting elevated amounts can also increase the risk of dangerous respiratory depression.
The recalled gripe water was sold in 4-fluid-ounce (118 ml) amber bottles and distributed with an oral syringe. It was sold nationwide online via Amazon and through Secrets of Tea, an organic herbal remedies retailer. The product is marketed as an over-the-counter liquid herbal supplement intended to soothe infant gas and hiccups, containing ingredients like ginger root and sodium bicarbonate. Its sleep support is attributed to a proprietary blend that includes chamomile, lemon balm, and passionflower.
Pacific Health Sciences stated that it has not received any reports of adverse events or injuries associated with the recalled product. Consumers are advised to stop using the product immediately and either discard it or return it to the point of purchase for a full refund. Pacific Health Sciences can be reached by phone at (310) 457-1775 or by email at [email protected], Monday through Thursday from 9:30 a.m. to 5 p.m. PT.