Federal health regulators have announced a recall for Garden of Life’s Baby Organic Liquid Formula, due to labeling problems that may cause confusion and result in a choking hazard for infants.
The Baby Organic Liquid Formula recall was announced by the FDA on September 7, since the current label directions may be misinterpreted. If the product is not administered precisely, it may result in swallowing problems and potentially cause an infant to choke due to the thickness of the liquid.
Garden of Life LLC initiated the voluntary recall as a precautionary measure, to make it clear that the product should only be administered by mixing it in either breast milk or formula, and that it should not be adminstered directly into the infant’s mouth.
Baby Organic Liquid is a probiotic supplement designed specifically for infants. Its ingredients are designed and intended as safe for infants. However, the company became concerned after a parent had difficulties safely administering the liquid to the newborn’s mouth.
The product comes in a blue carton that includes a measuring syringe, and prior label instructions warn parents, “Do not insert syringe directly in mouth. Dispense liquid slowly into the mouth, toward the inner cheek. May be mixed with breast milk or formula.”
Garden of Life indicates the instructions may be confusing or complicated for parents, thus they may be interpreted incorrectly. If the liquid is not mixed with breast milk or formula, infants may have difficulty swallowing the product or they may choke on the liquid because the liquid is too thick.
New labels for the Baby Organic Liquid Formula will include instructions that call on parents to only give the product to the infant after mixing with breast milk or formula. It would also warn against administrating the liquid directly into the infants mouth.
So far, no hospitalizations or injuries have occurred. However, Garden of Life is taking the problem seriously and taking immediate precautions to prevent any infant injuries.
Baby Organic Liquid Formula is a part of the Dr. Formulated product line which was released within the last two weeks. It is sold only in the U.S., with limited distribution. A limited number of natural grocers, health food stores and online retailers sell the product. No other Garden of Life products are affected by the recall.
Garden of Life is calling on consumers who purchased the affected product to return the product to the retailer they purchased it from for a full refund. Consumers should refrain from using any unused product and simply return it for a refund.
The recall affects all lots of Baby Organic Liquid with UPC number 58010 12073: Lot numbers 5487617, 5487717, 5487817, and 5500817. All have expiration dates of 12/2018.
If you’ve administered the product to an infant and the infant experiences any adverse effects contact the FDA MedWatch program after receiving medical attention.