Perrigo Co. plc is recalling select Premium Infant Formula with Iron Milk-Based Powder sold under CVS Health and H-E-B Baby brands at the retailer and warehouse level citing elevated Vitamin D levels than permitted, according to the U.S. Food and Drug Administration.
The recall involves three lots within one batch, or 16,500 cans, of store brand Premium Infant Formula with Iron Milk-Based Powder.
The recalled product was shipped to H-E-B Grocery Co., LP in Texas, and CVS in around 12 states, such as TX, FL, CA, SC, VA, IN, TN, NJ, MI, PA, RI, MO.
T11LMYC with UPC: 050428318034 and USE BY 11NOV2025 was shipped to CVS beginning February 6.
Product shipped to H-E-B beginning February 2 include T11LMXC with USE BY 11NOV2025, and T09LMXC with USE BY 09NOV2025. The UPC is 041220164578.
No other products or retailers are impacted by the recall.
The recall was initiated in consultation with the FDA after elevated levels of Vitamin D in the product was determined through routine testing.
Short-term consumption of the affected lot codes is unlikely to cause adverse health implications for the vast majority of infants. Meanwhile, a small subset of physiologically vulnerable infants, such as with impaired renal function, may face health complications with the consumption of the recalled product.
However, there have been no reports of adverse events to date attributed to the elevated levels of Vitamin D in the impacted product.
Perrigo has asked H-E-B Grocery and CVS to examine their retail and warehouse inventory and isolate the product.
In similar recalls, Prosper, Texas-based Dairy Manufacturers Inc. in May called back infant formulas available under Crecelac and Farmalac brands as they were sold in the U.S. without complying with the infant formula regulations of the U.S. Food and Drug Administration.
Healthwest Minerals, Inc. d/b/a Mt. Capra Products in early May recalled 1,506 boxes of Goat Milk Formula Recipe Kit as it did not meet all FDA requirements for infant formula.
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