Baby formula recalled from CVS, H-E-B in 12 states due to exceedingly high levels of vitamin D

A baby formula product shipped to H-E-B and CVS stores in 12 states has been recalled due to excessive levels of vitamin D, which can cause health complications for vulnerable infants.

Perrigo Company issued the voluntary recall Thursday for three lots within one batch, or 16,500 cans, of its Premium Infant Formula with Iron Milk-Based Powder, a notice posted by the U.S. Food and Drug Administration said.

U.S. Food and Drug Administration

The affected product was shipped to H-E-B stores in Texas starting Feb. 2 and to CVS stores in Texas, Florida, California, South Carolina, Virginia, Indiana, Tennessee, New Jersey, Michigan, Pennsylvania, Rhode Island and Missouri starting Feb. 6.

At H-E-B, the recalled formula carries the lot codes of T11LMXC with a use-by date of Nov. 11, 2025, and T09LMXC with a use-by date of Nov. 9, 2025. CVS' recalled formula has the lot code T11LMXC and a use-by date of Nov. 11, 2025. Perrigo said it's now notified both stores to remove the product from shelves and warehouses.

Routine testing revealed the Premium Infant Formula had levels of vitamin D exceeding the maximum permitted level, but no adverse events have been reported related to the recall yet, the FDA said.

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For most infants, the FDA said consuming excessive amounts of vitamin D is unlikely to cause health complications, but in a "small subset of physiologically vulnerable infants," like those with impaired renal function, consuming the recalled product could cause adverse health effects.

The CDC says children younger than 12 months old need 400 IU of vitamin D each day to support the development of strong bones. Breast milk typically doesn't provide the needed amount, so babies who are solely breastfed typically need supplementation, such as through vitamin D-fortified formula.

But too much vitamin D can be harmful to babies because it increases calcium levels in the blood, which can then be deposited in the kidneys and cause damage, the CDC says. Infants with excess vitamin D levels may experience vomiting, frequent thirst or urination, limb pain, constipation and more.

Infants experiencing any symptoms after consuming the recalled product should contact their health care provider and notify the FDA's MedWatch Adverse Event Reporting program at fda.gov/medwatch/report.htm .

For the full recall notice, click here .