FDA MedWatch - “Angel Formula” Infant Formula by Moor Herbs
U.S. Food and Drug Administration sent this bulletin at 01/10/2022 10:10 AM EST
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MedWatch - The FDA Safety Information and Adverse Event Reporting Program
TOPIC: “Angel Formula” Infant Formula by Moor Herbs: Recall - Due to Possible Health Risk
AUDIENCE: Pediatrics, Consumer, Health Professional
ISSUE: Moor Herbs is recalling its Angel Formula because FDA testing determined that the product did not meet specific nutrition and labeling requirements for infant formula, even though it is marketed as such. When the product was tested, the iron, sodium, and potassium content were well over the maximum allowed which could potentially lead to iron overload and/or electrolyte imbalances. In addition, the product did not have vitamin D and a vitamin D deficiency can potentially lead to rickets, a softening and weakening of bones. All units in distribution are included in this recall.
No illnesses or injuries have been reported to date.
For more information about this recall, click on the red button Read Recall below.
BACKGROUND: This product is marketed as an infant formula (i.e., products intended as a complete or partial substitute for human milk for children 12 months old and younger) but the required pre-market infant formula notification for this product has not been submitted to the FDA.
RECOMMENDATIONS:
Parents and caregivers of infants who have purchased the recalled product should discontinue use and either throw the product away or return for a refund.
Parents and caregivers of infants who have used these products and are concerned about the health of their child should contact their health care provider.
Consumers and health professionals are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
