The Food and Drug Administration (FDA) issued a statement this week alerting U.S. consumers to the voluntary recall of a baby supplement available on Amazon due to regulatory noncompliance.
Following a recent inspection by the health authority, it was discovered that Baby Sleep Gripe Water, a medication designed to alleviate cramping and stomach issues in infants, contained undisclosed natural alcohols, which were not listed on the product's label.
The FDA has reported no adverse effects in infants to date, however, the agency acknowledges that exposure to these compounds may pose a risk to infants, contingent upon the quantity ingested, their age, and body weight.
The FDA has provided a detailed description of the product in question, which was sold on Amazon. The product, identified as Babies' Magic Tea's Water Baby Sleep Gripe, consisted of a 4-ounce liquid solution contained in an amber bottle and accompanied by an oral syringe. The product was packaged in a blue cardboard box and bore a batch number of 25122bw, with an expiration date set for December 2028.
A popular natural remedy known as "Gripe Water" has been widely marketed to alleviate stomach disorders, but it remains unregulated by the FDA and lacks concrete scientific evidence to support its claimed benefits.
The FDA advises consumers to either discard the product or return it to the store of purchase for a refund. Affected customers are also encouraged to report any adverse reactions to the product by contacting Pacific Health Sciences at 310-457-1775 or submitting a message to myorder@pacifichealth.com.
