US FDA Recalls Baby Sleep Supplement Containing Alcohol

A baby sleep supplement sold online has been recalled after testing detected three types of alcohol that were not listed on its label, according to the US Food and Drug Administration (FDA).

Pacific Health Sciences voluntarily recalled one lot of Babies’ Magic Tea Baby Sleep Gripe Water on October 6 after FDA testing identified ethanol, methanol and isopropanol in the product.

The company reported concentrations of approximately 8.3% ethanol, 0.35% methanol and 0.48% isopropanol. It warned that the substances could pose health risks depending on the quantity consumed and the user’s age and body weight.

The recall affects products bearing lot number 25122bw. They come in four-ounce (118 mL) amber bottles packaged in blue cardboard boxes. The lot number is printed on the bottom of the box and on a side panel of the bottle. Each package also contains an oral syringe.

The affected supplements were sold through the Secrets of Tea website and Amazon.

Parents and caregivers who have the affected product should stop using it immediately and either discard it or return it to the place of purchase for a refund. Anyone whose child experiences symptoms after using the supplement should seek medical attention and contact Pacific Health Sciences. Consumers can also report adverse reactions to the FDA through its MedWatch reporting system.