The American Food and Drug Administration (FDA) has assigned the second highest risk level to a recall of infant formula due to its high vitamin D content.
The product, Perrigo's Premium Infant Formula with Iron-Enriched Milk Powder, was first recalled on August 8 due to concerns that it contained levels of vitamin D that exceeded the maximum permitted amount.
The FDA has now assigned the products to Class II. This classification level is assigned “to a situation in which use of or exposure to an unlawful product may result in temporary or medically reversible adverse health consequences or the likelihood of serious adverse health consequences is remote.”
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Perrigo is the third largest manufacturer of infant formula for the US and Canadian markets. The recall affects 16,500 stores in 12 states.
The formula was distributed to HEB Grocery Company in Texas and CVS stores in Texas, Florida, California, South Carolina, Virginia, Indiana, Tennessee, New Jersey, Michigan, Pennsylvania, Rhode Island and Missouri.
Newsweek sent an email to Perrigo outside of normal business hours requesting a comment.
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The increased vitamin D content in the formula was initially detected during routine testing. To date, no adverse events have been reported in connection with the formula.
The FDA press release states: “For the vast majority of infants, short-term consumption of the affected lot numbers is unlikely to result in adverse health consequences. For a small subset of physiologically vulnerable infants (e.g., those with impaired renal function), there is a potential that consumption of the recalled product could result in health complications.”
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“Parents and guardians who may have purchased the product should look for the lot numbers listed below with the best-before dates located on the bottom of the packaging and contact their healthcare provider with any concerns.”
The codes of the recalled products are as follows:
Product delivery to CVS from February 6, 2024:
- T11LMYC – EXPIRATION UNTIL 11.11.2025 (Material: 975261, UPC: 050428318034)
Products shipped to HEB Grocery Company, LP beginning February 2, 2024:
- T11LMXC – EXPIRATION UNTIL 11/11/2025 (Material: 788362, UPC: 041220164578)
- T09LMXC – EXPIRATION UNTIL 09.11.2025 (Material: 788362, UPC: 041220164578)
Vitamin D is an important nutrient for babies. It supports the growth of healthy bones and prevents rickets – the softening of the bones.
According to the Centers for Disease Control and Prevention (CDC), children under 12 months of age need 400 international units (IU) of vitamin D daily.
Children aged 12–24 months need 600 IU per day.
Babies fed only breast milk or breast milk and infant formula need 400 IU of vitamin D shortly after birth. However, if a baby is fed only infant formula, he or she does not need additional vitamin D—the infant formula contains everything he or she needs.
