Urgent Recall! Perrigo Recalls 16,500 Cans of Baby Formula Proactively, Warning of Vitamin D Overdose Risk

Dublin, Ireland and Aragon, MI - August 8, 2024 - Perrigo Company plc announced that it is voluntarily recalling certain lots of three store-brand premium infant formula, totaling 16,500 cans, as a precautionary measure. The reason for the recall is that the vitamin D content of these products exceeds the maximum allowed limit. The affected products have been distributed to H-E-B Grocery Company in Texas and CVS stores in Texas, Florida, California, South Carolina, Virginia, Indiana, Tennessee, New Jersey, Michigan, Pennsylvania, Rhode Island and Missouri. The recall is limited to these batches and retailers, and other products and retailers are not affected.

The company decided to conduct this voluntary recall after consulting with the Food and Drug Administration (FDA). At present, no adverse events have been reported due to high levels of vitamin D in the products. The problem was discovered during routine quality testing. For most infants, consumption of products from these affected batches is unlikely to cause health problems in the short term. However, in a small percentage of infants who are more physiologically vulnerable (for example, those with impaired kidney function), consumption of the recalled product may pose a health risk. Parents and guardians who may have purchased these products should check the lot code and "best by date" on the bottom of the product packaging and contact their healthcare provider immediately if they have any concerns.

According to the U.S. Food and Drug Administration (FDA), the following clear standards are set for vitamin D content in powdered milk: For infant formula, it must contain at least 400 international units (IU) of vitamin D per 100 calories; For infant formula, the amount of vitamin D per 100 calories should be maintained between 400 and 800 IU. These requirements generally apply to all infant and infant formula products circulating in the U.S. market.

Given the critical role vitamin D plays in promoting healthy bone growth and optimizing calcium absorption in infants and young children, ensuring adequate vitamin D content in milk powder is particularly important. The above standards are designed to ensure that infants and young children can obtain vitamin D levels that meet their growth and development needs through the consumption of milk powder.

Perrigo has taken swift steps to notify H-E-B Grocery Company and CVS directly, asking them to check inventory in retail and warehouses and quarantine these products.