Home / Graceleigh, Inc. dba Sammy's Milk / F-1247-2024
Class I
Graceleigh, Inc. dba Sammy's Milk
Recall #F-1247-2024 · Initiated 2024-04-18
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.
Quantity affected
1,465 units of 25.68 oz Pouches
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.
Lot / code info
Lot Code SD348, Best by date of August of 2025
Voluntary / mandated
Voluntary: Firm initiated
Initial notification
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Terminated
2024-05-24
Recalling firm
Graceleigh, Inc. dba Sammy's Milk
3471 Via Lido Ste 207
Newport Beach, CA 92663-3929
United States
Recall classification
Most serious. Reasonable probability that the product will cause serious health consequences or death.