Mt. Capra Issues Goat Milk Formula Recall Following Report of Infant Anemia

Mt. Capra issued a goat milk formula recall on May 10, 2024 after an adverse event involving an anemic infant was reported.

Mt. Capra Goat Milk Formula Recall

The recall involves 1,506 boxes of the Mt. Capra Goat Milk Formula Recipe Kit sold online through the company’s web store and a retail location in Chehalis, Washington from 05/01/2023 to 05/01/2024.

Affected lot numbers include: 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.

What Was the Reason for the Goat Milk Formula Recall?

The Mt. Capra Goat Milk Formula Recipe Kit recall was initiated following a recommendation by the US. Food and Drug Administration (FDA) because the agency is concerned that the formula does not meet all of the FDA requirements for infant formula.

Additionally, the FDA indicates that the formula may not provide sufficient nutrition when it is used as an infant formula. The storage instructions may also be insufficient for the product.

The FDA is concerned that infants consuming the recalled product “without additional iron supplementation can develop iron deficiency anemia and feeding intolerance.”

At least one adverse event has been reported so far.

One Infant Sick So Far

One infant has become sick so far from consuming this Mt. Capra Goat Milk Formula Recipe.

After an infant child was diagnosed with anemia, this diagnosis prompted a U.S. Food and Drug Administration (FDA) investigation. The FDA notified the maker.

According to reports, the caregivers were using the Goat Milk Formula Recipe Kit and accompanying recipe. However, they did indicate that some ingredient substitutions were made that ultimately created a product that was deficient in vitamin B12 as well as folate, which ultimately resulted in the development of anemia.

Flaws in the Recipe

The problem that resulted in an adverse effect resulting in infant anemia stems from flaws in the recipe.

While the recipe, as written, may meet the criteria established by the FDA for infant formula dietary requirements, potential substitutions that may alter those nutrient levels can cause serious negative effects.

According to the Mt. Capra website, an 8 oz bottle requires six ingredients. An additional four ingredients to be given in “just ONE bottle per day.”

To make one bottle, a caregiver must carefully measure not only the provided Whole Goat Milk Powder, but additional goat milk lactose powder, goat milk ghee or coconut oil, extra virgin olive oil, expeller-pressed grapeseed oil, and unsulphured blackstrap molasses. The once-a-day vitamin bottle is expected to include Head Start^TM Multi vitamin powder, Nordic Naturals^® DHA Infant powder, goat milk colostrum, and Flora Start^TM Kids Probiotics powder.

That is a lot of steps and may lead caregivers to substitute products, as was the case in this situation. The caregiver indicated using a different brand of vitamin, which lead to the infant’s anemic state.

Conflicting Information

Consumers looking for information may find conflicts between the Mr. Capra website and the FDA recall notice.

According to the recall notice: “The firm does not recommend using this product for infants from 0-12 months of age. If you have prepared and fed your infant Mt. Capra formula from their Goat Milk Formula Recipe Kit, we recommend you contact a healthcare provider to discuss if testing for nutritional deficiencies is recommended.”

However, while the website isn’t explicitly indicating whether or not this formula is meant for older children or infants, responses to questions in the comments indicate otherwise.

For example, in 2021, one potential consumer asks:

“I’m currently pregnant and am very interested in this formula! Is this ok to use with newborns? For 2oz bottles do I make a whole 8oz and split it through out the day when baby is hungry?? If I refrigerate the extra milk do I use a bottle warmer to warm the milk back up? And how do I find out how much DHA to use for my newborn, are the multivitamin ok to use for a newborn? The products for once a day use how do I cut them down for 2-4oz bottles since the baby will be a newborn.”

The response:

“Congrats on being pregnant. Many people have successfully used this with newborns. Have you joined us over at https://www.facebook.com/groups/goatmilkformula? We hit on a lot of those concerns there and its a great community of support. Come and join us!” – Joe Stout, M.S.

Infant Formula is a Highly Regulated Product

Infant formula is a highly regulated product. It is often the sole source of nutrition for infants (defined as children up to 12 months of age).

In addition to nutritional adequacy and safety, certain packaging and labeling requirements are mandated by the FDA.

Nutritional Requirements

The FDA specifies that 30 nutrients must be included in infant formulas as well as the minimum amounts of each. For 10 of those ingredients the agency sets a maximum level.

Sanitation Controls

All ingredients used in infant formula must be “safe and suitable for such use” and certain facility controls to ensure that safety. Water used by an infant formula manufacturer must also meet certain safety standards set by the U.S. Environmental Protection Agency (EPA).

Labeling Requirements

Certain labeling requirements are mandated by the FDA. These include clear directions for preparation and use, complete with pictogram depicting major steps for preparing infant formula. A “use-by” date is also required.

Both Domestic and Imported Infant Formula Must Meet the Same Requirements

Whether produced domestically or imported, any infant formula sold in the United States must meet the U.S. requirements for safety and nutritional adequacy.

Sometimes infant formula products are sold online or through third-party distributors. In these cases, an FDA premarket review may not have been conducted. Use caution when ordering imported infant formula products online.

If Your Infant Has Been Impacted By This Goat Milk Formula Recall, You May Need Legal Advise

If your infant has been impacted by this goat milk formula recall, a food safety lawyer may be able to help. The trusted lawyers at The Lange Law Firm, PLLC have helped so many families hold those responsible for their role in illness and more.

Call (833) 330-3663 or click here for a free consultation.

By: Heather Van Tassell (contributing writer, non-lawyer)