A recall of infant formula has been given the second-highest level of risk classification by the Food and Drug Administration (FDA) due to high levels of Vitamin D.
The product, Perrigo’s Premium Infant Formula with Iron Milk-Based Powder, was initially recalled on August 8 over concerns that it contained levels of Vitamin D that were over the maximum permitted amount.
The FDA has now designated the products as Class II. This classification level is given to “a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
Perrigo is the third-largest manufacturer of infant formula for the U.S. and Canadian markets. The recall affects 16,500 units across 12 states.
The formula was distributed to H-E-B 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 emailed Perrigo for comment outside of normal working hours.
The elevated Vitamin D levels in the formula were initially detected during routine testing. No adverse events related to the formula have yet been reported.
The FDA press release states: “For the vast majority of infants, short-term consumption of the affected lot codes is unlikely to cause adverse health implications. In a small subset of physiologically vulnerable infants (e.g., impaired renal function), there is the potential that consumption of the recalled product could result in health complications.”
“Parents and caregivers who may have purchased the product should look for the lot codes below with “use by” dates, which can be found on the bottom of the package and should contact their health care provider if they have any concerns.”
The codes for the products being recalled are as follows:
Product shipped to CVS beginning February 6, 2024:
- T11LMYC – USE BY 11NOV2025 (Material: 975261, UPC: 050428318034)
Products shipped to H-E-B Grocery Company, LP beginning February 2, 2024:
- T11LMXC – USE BY 11NOV2025 (Material: 788362, UPC: 041220164578)
- T09LMXC – USE BY 09NOV2025 (Material: 788362, UPC: 041220164578)
Vitamin D is an essential nutrient for babies. It helps to support the growth of healthy bones and prevents rickets – the softening of bones.
According to the Centers for Disease Control and Prevention (CDC), children under 12 months need 400 international units (IU) of Vitamin D each day.
Children aged 12-24 months need 600 IU per day.
Babies fed only breast milk or breast milk and infant formula will need 400 IU of Vitamin D shortly after birth. However, if a baby is only fed formula, then they do not need additional Vitamin D – the formula contains all they need.
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