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Graceleigh, Inc. dba Sammy's Milk
FDA recall F-1248-2024 · Class I · reported 2024-05-29 · Terminated
- Product
- Sammy's Milk GOAT MILK TODDLER FORMULA, 0.64oz (18.2g) Stick Pak
- Reason
- 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.
- Quantity
- 2,487 units of 0.64oz Stick Paks
- 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.
- Firm location
- CA, United States
- Initiated
- Voluntary: Firm initiated
- First notice
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Recall started
- 2024-04-18
- Terminated
- 2024-05-24
- Code info
- Lot Code SD348, Best by date of August of 2025
Source: U.S. Food and Drug Administration, openFDA Food Enforcement database (openFDA Food Enforcement, imported 2026-09). The FDA does not validate openFDA data for completeness or accuracy. This is a record of an enforcement action, not safety advice.