FDA Recalls 16,500 Cans of Baby Formula Over Health Fears

The U.S. Food and Drug Administration (FDA) is warning parents of newborns to avoid batch from a brand of infant formula because it contains excessive amounts of Vitamin D. 

The FDA has issued a recall for 16,500 cans of the formula, which was sold in CVS and H-E-B stores in 12 U.S. states. The recall was posted August 8 and applies to formula made by the Perrigo Company. The variety in question is called Premium Infant Formula with Iron Milk-Based Powder. The batch is too high in Vitamin D, but the FDA said it was probably not dangerous for most babies, and if it is consumed for a short time. 

But children with physiological vulnerabilities should not be fed the formula, the agency said. The FDA said “routine testing” found the elevated levels of Vitamin D, but that no parents have reported “adverse events” tied to the infant formula. 

A Vitamin D overdose, which does not appear likely for those consuming this powdered formula, can lead to calcium build-up in the blood. Symptoms of acute toxicity can include nausea, weakness, and excess urination. 

The batch of Perrigo formula was sent to H-E-B grocery stores in Texas on February 2. On February 6, the company distributed the batch to CVS pharmacies in California, Florida, Virginia, South Carolina, Tennessee, Indiana, Michigan, New Jersey, Rhode Island, Pennsylvania, and Missouri. The company has contacted H-E-B to request that any packages be removed from both warehouses and store shelves. 

Parents who suspect they may have bought the recalled formula should check the packaging for lot and batch codes as well as “use by” dates. All of these are found on the bottom of the packages. 

Here’s what to look for: 

Use-by date: Nov. 11, 2025; Nov. 9, 2025

Code for the affected lot: Lot code: T11LMXC

Though the FDA said any serious health effects are unlikely, parents should monitor their infant’s health and contact a doctor if they have any concerns.