What’s New
July 31, 2024
After conducting an abbreviated nutrient analysis of Crecelac Infant Powdered Goat Milk Infant Formula, the FDA found both elevated levels of potassium and chloride and low levels of Vitamin A. The potassium and chloride levels were significantly above the levels permitted in infant formula in the U.S. and could lead to kidney and/or heart problems if the infant formula is used for an extended period of time. In addition, low Vitamin A intake could lead to vision loss from a Vitamin A deficiency if the infant formula is used for an extended period of time.
As this product was part of a voluntary recall that the company initiated on May 24, 2024, all caregivers should have already disposed of the product and discontinued use. If you have continued to use this product, the FDA recommends discontinuing any further use. Parents and caregivers who used this product and have concerns should consult with their health care providers.
Audience
- Parents and caregivers of infants who consume infant formula.
Summary of Problem and Scope
The FDA has determined that the infant formula products listed above were sold in the U.S. illegally because, among other things, the company has not submitted to the FDA the required premarket notification.
On May 21, 2024, the FDA recommended that the firm recall the infant formula products to which the firm agreed. As the FDA continued its investigation, the agency identified Cronobacter in a sample of the recalled Crecelac infant formula product. The FDA notified Dairy Manufacturers Inc. of these findings and they agreed to update their recall press release to include the laboratory results.
The FDA is continuing to work with the firm and its distributors to ensure the recall is effectively executed.
Further Information for Consumers
The FDA is issuing this advisory because infants that consume these products could be at risk of potentially severe infection due to the Cronobacter contamination. The FDA advises parents and caregivers not to feed these infant formula products to infants under their care. If your infant is experiencing symptoms related to Cronobacter infection, such as poor feeding, irritability, temperature changes, jaundice, grunting breaths, or abnormal body movements, contact your health care provider to report their symptoms and receive immediate care.
If caregivers are looking for an alternative goat milk infant formula for sale in the U.S., they may wish to speak with their infant’s health care provider, as there are goat milk infant formulas that either have completed the required FDA premarket notification process or are currently being marketed under the FDA’s enforcement discretion policy.
Additionally, parents and caregivers can find more information on safe infant feeding practices on the FDA’s infant formula landing page.
Recommendation for Consumers
To report a complaint or adverse event (illness or serious allergic reaction), you can:
- Call an FDA Consumer Complaint Coordinator ;if you wish to speak directly to a person about your problem.
- Complete an electronic Voluntary MedWatch form online.
- Complete a paper Voluntary MedWatch form that can be mailed to FDA.
