F-1248-2024 Class I Terminated

Recalled by Graceleigh, Inc. dba Sammy's Milk — Newport Beach, CA

Recall Details

Product Type
Food
Report Date
May 29, 2024
Initiation Date
April 18, 2024
Termination Date
May 24, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2,487 units of 0.64oz Stick Paks

Product Description

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

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 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 Pattern

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.

Code Information

Lot Code SD348, Best by date of August of 2025