Class I · High riskTerminated Initiated Apr 18, 2024 (2 years ago)
Sammy's Milk GOAT MILK TODDLER FORMULA recall
Recalled by Graceleigh, Inc. dba Sammy's Milk · Newport Beach, CA, United States
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
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.
FDA's distribution note: 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.
Do not eat it. Class I means FDA judged there is a reasonable probability of serious illness or death. If the brand, size and lot or date code on your package match, throw the product away or return it to the store for a refund, and clean any surface or container it touched. If anyone has eaten it and feels unwell, contact a doctor and mention the recall. FDA lists this recall as terminated: the company has finished removing the product, so it should no longer be on shelves - but it can still be in a freezer or pantry.
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…
Graceleigh, Inc. dba Sammy's Milk 43 statesF-1248-2024