FDA MedWatch - Baby Organic Liquid Formula by Garden of Life: Recall - Directions For Use May Be Misinterpreted

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Baby Organic Liquid Formula by Garden of Life: Recall - Directions For Use May Be Misinterpreted

AUDIENCE: Consumer

ISSUE: Garden of Life, LLC is issuing a voluntary precautionary recall of its new supplement for infants, Baby Organic Liquid, because the product, as labeled, includes directions for use that may be misinterpreted. The company is concerned that if not administered precisely following the labeled instructions, the product may present difficulties in swallowing and potentially pose a choking hazard due to the thickness of the liquid.

Baby Organic Liquid is a liquid supplement packaged in a blue carton that includes a measuring syringe. The label currently instructs 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.” The company is recalling the product in order to relabel it with new instructions, advising parents to only administer the product by mixing in either breast milk or formula and not to administer directly into the infant’s mouth.

This recall affects all lots of Organic Baby Liquid.

BACKGROUND: Baby Organic Liquid is only sold in the USA at a limited number of natural grocers, health food stores and online. This recall arose after learning that a parent had difficulties with the safe administration of the product into a newborn’s mouth. The ingredients in Baby Organic Liquid are safe for infants.

RECOMMENDATION: Garden of Life is asking any customers who purchased Baby Organic Liquid to return the product to their store of purchase for a full refund.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including a link to the press release, at:

https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm575214.htm