16,500 Cans of Infant Formula Recalled Over Risk of ‘Health Complications’

A can of Premium Infant Formula with Iron Milk-Based Powder that is being recalled. (FDA

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 Ireland-based company is recalling “Premium Infant Formula with Iron Milk-Based Powder” sold under brand names, CVS Health and H-E-B Baby, according to an Aug. 8 notice by the Food and Drug Administration (FDA).

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 The items are being withdrawn after being identified as containing “levels of Vitamin D above the maximum level permitted.”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 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.”

Perrigo asked customers to inform any adverse effects on infants to the FDA’s MedWatch Adverse Event Reporting program. Customers can contact Perrigo Consumer Affairs at 1-800-538-9543 to clarify any questions.

Earlier in February, another infant product was recalled due to similar issues. Nordic Naturals pulled out its brand of Baby’s Vitamin D3 Liquid items due to elevated levels of Vitamin D3. The recall pertained to 3,800 units, and the company reporting no adverse events at the time.

High Vitamin D Risks

Vitamin D is crucial for babies as it helps them build strong bones and prevent rickets or a softening of the bones, according to the U.S. Centers for Disease Control and Prevention (CDC).

All children require a certain amount of vitamin D shortly after they are born. “Children who are deficient in vitamin D have a 2000-fold risk of fracture compared with those with normal vitamin D levels,” a July 2023 study stated.

Infants found to be deficient in vitamin D are given supplements, the CDC states. Babies who take infant formula may not need any supplementation.

However, giving excessive amounts of vitamin D can end up harming infants, causing hypercalcemia and hypercalciuria, the study warned.

Hypercalcemia occurs when there is a high level of calcium in the blood, which can lead to weak bones, kidney stones, and also affect the brain and heart. Hypercalciuria occurs when the urine contains excess calcium which can cause salts to crystalize, resulting in pain and urinary symptoms.

High vitamin D intake can also lead to “an imbalance in bone metabolism, fatigue, diarrhea, dehydration, weight loss … confusion, psychosis, nausea, and parathyroid hormone imbalance” among babies, the study noted.

ANSES, the French agency for food, environmental, and occupational health & safety, warns parents against using food supplements to provide vitamin D to children. It instead recommends opting for medications for children deficient in the vitamin.

“Medicines provide clear information on doses, precautions for use, risk of adverse effects and overdose,” it said.

The agency also highlighted the importance of “carefully controlling the doses given to your child, and avoiding combining different products containing vitamin D, in order to prevent overdoses that could impair kidney function.”