WASHINGTON, D.C. — The Food and Drug Administration (FDA) announced that Perrigo Company plc initiated a voluntary recall at the retailer and warehouse level of three lots within one batch, totaling 16,500 cans, of store brand Premium Infant Formula with Iron Milk-Based Powder. The recall is due to Vitamin D levels exceeding the maximum permitted amount. The affected product was shipped to H-E-B Grocery Company, LP in Texas, and CVS in multiple states including Texas, Florida, California, Pennsylvania, and others.
Perrigo is conducting this recall in consultation with the FDA. No adverse events have been reported in relation to the elevated Vitamin D levels, which were discovered through routine testing.
For most infants, short-term consumption of the affected lot codes is unlikely to cause health issues. However, a small group of physiologically vulnerable infants, such as those with impaired renal function, may face potential health complications. Parents and caregivers who purchased the product should check the lot codes and “use by” dates on the bottom of the package. They should contact their healthcare provider if they have concerns.
The recalled products include:
- Product shipped to CVS (beginning February 6, 2024):
- Lot Code: T11LMYC – USE BY 11NOV2025
- Material: 975261, UPC: 050428318034
- Product shipped to H-E-B Grocery Company, LP (beginning February 2, 2024):
- Lot Code: T11LMXC – USE BY 11NOV2025
- Lot Code: T09LMXC – USE BY 09NOV2025
- Material: 788362, UPC: 041220164578
No other lot codes are affected by this recall.
Perrigo has immediately notified H-E-B Grocery Company, LP and CVS to check their inventory and isolate the impacted product. Parents and caregivers are advised to report any symptoms experienced by infants using the product to the FDA’s MedWatch Adverse Event Reporting program.
For any questions or concerns about the recall or related adverse events, Perrigo Consumer Affairs can be contacted at 1-800-538-9543, Monday through Friday, from 8:00 am to 5:00 pm EST.
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