FDA_FOOD campaign F-1248-2024
Class IHazard
FDA inspection and investigation of firm's website and social media pages found that Sammy's online marketing materials included misleading information that implied the product was safe as a sole source of nutrition for infants. Sammy's Milk has not submitted to FDA the premarket notification required for an infant formula, and the product is not manufactured in compliance with the infant formula requirements.
Distribution
U.S. Distribution to the following states: AL, AK, AZ, AK, CA, CO, CT, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MI, MN, MS, MO, MT, NV, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, TN, TX, UT, VT, VA, WA, WI, WY. All sales direct to consumer.
REKALLD area-alert coverage: nationwide (our reading of the distribution above)
The text above is quoted verbatim from the FDA_FOOD record. Confirm the affected units and the remedy with the manufacturer or FDA_FOOD. Recall data may be incomplete, delayed, or superseded.