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F-1248-2024Class I

Graceleigh, Inc. dba Sammy's Milk

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
Graceleigh, Inc. dba Sammy's Milk
Product type
Food / supplement / cosmetic
Status
Terminated
Report date
2024-05-29
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 state
CA
Product quantity
2,487 units of 0.64oz Stick Paks
Initiated by
Voluntary: Firm initiated
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.

Product description

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

Code / lot info

Lot Code SD348, Best by date of August of 2025

Other recalls SPEQ maps to Documentation & Change Control
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Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →