Graceleigh, Inc. dba Sammy's Milk recalls Sammy's Milk GOAT MILK TODDLER FORMULA, 0.64oz (18.2g) Stick Pak

Recall date

April 18, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

F-1248-2024

FDA classification

Class I

Brand / firm

Graceleigh, Inc. dba Sammy's Milk

Sold / distributed

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.

Why it was recalled

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.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Sammy's Milk GOAT MILK TODDLER FORMULA, 0.64oz (18.2g) Stick Pak