Mt. Capra Goat Milk Formula Kit Recalled for Lack of FDA Premarket Notification
Mt. Capra Goat Milk Formula Recipe Kit recalled for marketing as infant formula without FDA premarket notification.
The agency’s classification
FDA (Food): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This recall is classified as FDA Class I, which per the severity guidelines establishes a minimum score of 4. The product was marketed as infant formula without the required premarket FDA notification and review.
Plain-English summary
Healthwest Minerals, Inc. dba Mt. Capra Products is recalling Mt. Capra Goat Milk Formula Recipe Kit (10 lbs 8 oz) and Bundle Refill nationwide. The product consists of ten individually packaged ingredients including whole goat milk, goat milk lactose, goat milk ghee, oils, molasses, vitamins, colostrum, and probiotics. Approximately 1506 boxes have been distributed. The Bundle Refill contains three core ingredients: whole goat milk, goat milk lactose, and goat milk ghee.
The product is being recalled because it has been marketed as infant formula without submitting the FDA premarket notification required for such products. Federal regulations require manufacturers to submit infant formula products for FDA premarket review before marketing or distribution.
Consumers who have purchased this product should discontinue use and consult with a healthcare provider about safe feeding alternatives for their infant.
The recalled product
- Product
- Mt. Capra Goat Milk Formula Recipe Kit (net wt. 10lbs. 8oz.) and Bundle Refill. Each Goat Milk Formula Recipe Kit consist of 10 individually packaged ingredients: *Whole Goat Milk *Goat Milk Lactose *Goat Milk Ghee -Extra Virgin Olive Oil -Expeller-Pressed Grapeseed Oil…
- Manufacturer
- Healthwest Minerals, Inc. dba Mt. Capra Products
- Category
- Food — Infant Formula
- Affected units
- 1,506
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 13150423
- 13150723
- 13151223
- 13151323
- 13151623
- 13151823
- 13151923
- 13152123
- 13152423
- 13152523
- 13152623
- 13152823
- 13153023
- 13153123
- 13153423
- 13153523
- 13153723
- 13153923
- 13154123
- 13154423
Distribution
Distributed nationwide across the United States.
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