Pharmaceutical company Perrigo is pulling thousands of cans of infant formula from the U.S. market due to concerns that the items could lead to “health complications” in babies.

The voluntary recall is applicable to 16,500 cans that were shipped to multiple states including Texas, Florida, California, Tennessee, Indiana, and Pennsylvania. The items are being withdrawn after being identified as containing “levels of Vitamin D above the maximum level permitted.” The short-term consumption of the recalled items is “unlikely” to cause adverse health issues for a majority of infants, Perrigo stated.

However, “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,” it said.

Perrigo issued the recall after consulting with the FDA. No adverse events related to high levels of Vitamin D in the product have been reported. The recall affects three lots manufactured as part of a single batch.

The items sold under the CVS brand name have the UPC Code 050428318034 with a “Use By” date of Nov. 11, 2025. Products shipped to H-E-B have the UPC Code 041220164578 and “Use By” dates of Nov.

9, 2025, and Nov. 11, 2025. No other lot codes are affected, Perrigo said.

The company has asked both H-E-B and CVS to examine their retail and warehouse inventory to identify and pull out affected items from existing supplies. “Parents and caregivers.