RecallHawk
Class I Recall

Mt. Capra Goat Milk Formula Recipe Kit (net wt. 10lbs. 8oz.) and Bundle Refill. Each Goat Milk Formula Recipe Kit co

Healthwest Minerals, Inc. dba Mt. Capra Products

Summary

The FDA issued a Class I for Mt. Capra Goat Milk Formula Recipe Kit (net wt. 10lbs. 8oz.) and Bundle Refill. by Healthwest Minerals, Inc. dba Mt. Capra Products. Reason: The Goat Milk Formula Recipe Kit has been sold and marketed as infant formula, but product has not submitted to FDA the premarket notification require.

Details

Source

Food Recall

External ID

F-1347-2024

Action Date

2024-06-19

Status

Terminated

Category

food

Product Description

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 -Unsulphured, Blackstrap Molasses -Head Start Multivitamin Powder -Goat Milk Colostrum -Flora Start Kids Probiotics -Nordic Natural DHA Infants Bundle Refill consists of three individually packaged ingredients: *Whole Goat Milk *Goat Milk Lactose *Goat Milk Ghee

Lot/Code Info: 13150423, 13150723, 13151223, 13151323, 13151623, 13151823, 13151923, 13152123, 13152423, 13152523, 13152623, 13152823, 13153023, 13153123, 13153423, 13153523, 13153723, 13153923, 13154123, 13154423, 13154523, 13154723, 13154923, 13155023, 13155223, 13150124, 13150424, 13150624, 13150924, 13151024, 13151124, 13151224, 13151424, 13151624, 13151724, 13151824

Quantity Affected: 1506 boxes

Reason for Recall

The Goat Milk Formula Recipe Kit has been sold and marketed as infant formula, but product has not submitted to FDA the premarket notification required for an infant formula for review.

Distribution

nationwide

Type: Voluntary: Firm initiated

Recall Initiated: 2024-05-10

Context & Analysis

This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.

This was one of 88 food recalls issued in the same week, part of 204 food-related FDA actions this month.

Frequently Asked Questions

What is a Class I recall?

A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.

What should I do if I have this product?

Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Healthwest Minerals, Inc. dba Mt. Capra Products) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.

How often does Healthwest Minerals, Inc. dba Mt. Capra Products have FDA actions?

This is the only FDA action we have on record for Healthwest Minerals, Inc. dba Mt. Capra Products in our database.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "F-1347-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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