Perrigo Company plc is recalling 16,500 cans of store brand Premium Infant Formula with Iron Milk-Based Powder because of levels of Vitamin D above the maximum level permitted. 

The issue was determined through routine testing.

The recalled product was shipped to H-E-B Grocery Company, LP in Texas and CVS in the following states: Texas, Florida, California, South Carolina, Virginia, Indiana, Tennessee, New Jersey, Michigan, Pennsylvania, Rhode Island and Missouri.

Perrigo has taken immediate action by notifying H-E-B Grocery Company, LP and CVS directly and asking them to examine their retail and warehouse inventory and isolate the product.

The Company is initiating this voluntary recall in consultation with the U.S. Food and Drug Administration (FDA). 

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.

Recalled product:

Product shipped to CVS beginning Feb. 6, 2024, being recalled:

• T11LMYC – USE BY 11NOV2025
  (Material: 975261, UPC: 050428318034)

Product shipped to H-E-B Grocery Company, LP beginning Feb. 2, 2024, being recalled:

• T11LMXC – USE BY 11NOV2025
  T09LMXC – USE BY 09NOV2025
  (Material: 788362, UPC: 041220164578)

As of the posting of this recall, there have been no reports of adverse events to date attributed to the elevated levels of Vitamin D in the product subject to this recall.

If infants experience any symptoms while using the product, report them to the FDA’s MedWatch Adverse Event Reporting program online at www.fda.gov/medwatch/report.htm. Additionally, please get in touch with your healthcare provider.

(To sign up for a free subscription to Food Safety News, click here.)