According to a recall notice issued by the U.S. Food and Drug Administration (FDA) on February 15, the herbal supplement, which is administered orally to infants, contains an undissolved ingredient known as citrus flavonoid.
Children could potentially choke on this ingredient when drinking the gripe water, which also has ginger and fennel extracts and is often used by parents to relieve gas and similar stomach discomfort in babies. It’s a popular homeopathic remedy for infants with colic, too, which affects up to 25 percent of newborns between two weeks and three months of age.
“Use of the product should not be considered hazardous but could result in difficulty when swallowing the product for sensitive individuals,” the FDA explained in its statement.
So far, the FDA says that there has been one reported incident involving a one-week-old infant who had trouble swallowing the gripe water. Kingston Pharma LLC, the company that manufactures and sells the supplement, has also received three complaints from other customers.
The recall pertains to all lots of the DG Baby Gripe Water, which are sold at Dollar General stores across the U.S. in four-ounce amber bottles with white plastic caps and an oral syringe. The UPC code is “8 5495400246 3.”
Kingston Pharma urges consumers who have purchased the product to stop using it immediately and throw it away. They also advise parents to contact their healthcare provider if they believe their child has had an adverse reaction to the Baby Gripe Water.
Anyone who has questions regarding the recall or wishes to report an incident can contact Christina Condon or C. Jeanne Taborsky by phone at 844-724-7347 or by e-mail at Christina.Condon@SciRegs.com.