FDA recall F-1247-2024

Graceleigh, Inc. dba Sammy's Milk · Class I · food

Product

Sammy's Milk GOAT MILK TODDLER FORMULA, 25.68 oz (78g) pouch

Reason for recall

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 for use 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.

Key facts

Status
Terminated
Initiation date
2024-04-18
Report date
2024-05-29
Termination date
2024-05-24
Voluntary/Mandated
Voluntary: Firm initiated
Location
Newport Beach, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=F-1247-2024