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Recall Observatory FDA recall evidence

Food product

Sammy's Milk GOAT MILK TODDLER FORMULA, 25.68 oz (78g) pouch

F-1247-2024

April 18, 2024

Class I

Product summary

Firm
Graceleigh, Inc. dba Sammy's Milk
Event
Event 94462
Status
Terminated
Classification
Class I
Quantity
1,465 units of 25.68 oz Pouches
Official record key
food-enforcement:F-1247-2024

Official wording

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 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.

Code information: Lot Code SD348, Best by date of August of 2025

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.