Food Enforcement F-1247-2024

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.

Status

Terminated

Classification

Class I

Report Date

May 29, 2024

Recall Initiation

April 18, 2024

Product Information

Product description
Sammy's Milk GOAT MILK TODDLER FORMULA, 25.68 oz (78g) pouch
Product quantity
1,465 units of 25.68 oz Pouches
Product type
Food
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.
Initial firm notification
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
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.

Location & Firm

Recalling firm
Graceleigh, Inc. dba Sammy's Milk
Address
3471 Via Lido Ste 207

United States
Voluntary / Mandated
Voluntary: Firm initiated

Codes & Dates

Recall number
F-1247-2024
Event ID
94462
Recall initiation date
April 18, 2024
Center classification date
May 17, 2024
Code info
Lot Code SD348, Best by date of August of 2025
More code info