Baby Sleep Tea Recalled After FDA Finds Three Types of Alcohol Missing From the Label
A baby supplement sold online across the United States has been recalled after FDA testing found it contained three types of alcohol that were nowhere on the label. The company is asking parents to stop using it immediately.
According to the FDA recall notice, Pacific Health Sciences is voluntarily recalling one lot of its Babies' Magic Tea brand Baby Sleep Gripe Water. The affected lot is number 25122bw, with a best-before date of December 2028. It was sold in 4-ounce amber bottles packed inside blue cardboard boxes, each with an oral syringe included.
Lab testing found the lot contained 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 — the recalled batch's ethanol level is more than 16 times that ceiling.
The recall notice warns that the amounts recommended on the packaging could cause drowsiness, lack of coordination, behavioral changes, nausea, vomiting, and abdominal pain. Higher amounts raise the risk of respiratory depression and other serious consequences. "Organic alcohols such as ethanol, methanol, and isopropanol are known to impair normal functioning of the central nervous system," the notice says, adding that infant ethanol exposure has been linked to long-term developmental effects.
The FDA cautioned that "their presence may pose a risk depending on the amount consumed and the age and body weight of the person using the product." For a newborn weighing only a few kilograms, even small amounts are not something to take lightly.
The product's packaging advertises that it helps babies get "better sleep" and provides relief from gas, bloating, constipation, and acid reflux. Reports say it was marketed for babies as young as two weeks old. It was sold through online retailers, including the company's own website and Amazon.
Gripe water is classified as a dietary supplement in the US, so it does not need FDA premarket approval before going on sale. The FDA caught the problem in follow-up testing. The company says it has received no reports of adverse events tied to this lot.
Pacific Health Sciences advises parents and caregivers to stop using the recalled lot immediately — either discard it or return it to the place of purchase for a refund. Those who bought it on Amazon or the company's website can start with those channels.
If your baby had the product and seems unwell, call your pediatrician, or call the US Poison Control center at 1-800-222-1222. If the baby is having trouble breathing or is very hard to wake, call 911. For questions, the company can be reached at 310-457-1775 (Monday through Thursday, 9:30 a.m. to 5:00 p.m. Pacific) or myorder@pacifichealth.com.