F-1247-2024Class I

Graceleigh, Inc. dba Sammy's Milk

Recalling firm

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

Product quantity

1,465 units of 25.68 oz Pouches

Initiated by

Voluntary: Firm initiated

SPEQ quality domain

Documentation & Change Control

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.

Product description

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

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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See all Documentation & Change Control recalls →

Data: U.S. FDA openFDA enforcement API. 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.