Perrigo Company plc, of Dubin, Ireland, and Allegan, Michigan, has recalled 16,500 cans of CVS Health and H-E-B Baby-branded Premium Infant Formula with Iron Milk-Based Powder because the product was found to contain an excessive level of Vitamin D, reports the FDA.
Initiated by the company on August 8, 2024, the voluntary, retailer- and warehouse-level recall impacts three product lots within a single batch. The now-recalled products were distributed to, and made available for purchase at, H-E-B Grocery Company, LP in Texas, as well as to CVS, throughout the following states: Texas, Florida, California, South Carolina, Virginia, Indiana, Tennessee, New Jersey, Michigan, Pennsylvania, Rhode Island, and Montana.
Consumers should note that the recall does not cover any other product and does not impact any other retailer.
Perrigo Company plc first took action following a consultation with the U.S. Food and Drug Administration (FDA) and routine testing, which indicated a concentration of Vitamin D above the permitted level. Despite the finding, the company has not received any reports of illness or other adverse events in connection to the issue to date.
Officials say short-term consumption of products under the impacted lot codes is not likely to cause adverse health outcomes in the “vast majority of infants.” However, parents and caregivers are advised that consumption of the product by a small fraction of infants with physiological vulnerabilities, such as those with a disordered renal function, may cause health complications. To mitigate risks to those vulnerable, consumers are asked to be on the lookout for lot codes printed below the “use by” dates located at the bottom of the package. Those with health concerns should consult their healthcare provider.
Since the recall announcement, Perrigo has directly alerted H-E-B Grocery Company, LP, as well as CVS. Both retailers have been instructed to check their retail and warehouse inventory for recalled products and to have them isolated.
The following product codes, listed along with their “use by” dates, material numbers, UPCs (Universal Product Codes), and distribution information, are impacted:
- Product distributed to CVS starting February 6, 2024:
- T11LMYC – Use By 11NOV2025
- Material: 975261, UPC 050428318034
- Product distributed to H-E-B Grocery Company, LP, starting February 2, 2024:
- T11LMXC – Use By 11NOV2025
- T09LMXC – Use By 09NOV2025
- Material: 788362, UPC: 041220164578
As the FDA continues to monitor this recall, the agency asks that consumers report any related symptoms in infants to the MedWatch Adverse Event Reporting program.
Questions and concerns about the recall or adverse events may also be reported to Perrigo Consumer Affairs by calling 1-800-538-9543. Calls are monitored Monday through Friday, from 8:00 a.m. to 5:00 p.m. Eastern Time.
If your child has fallen ill and/or experienced an adverse health outcome that can be traced to an above-permitted level of Vitamin D in an infant formula product, we would like to learn about your story. Following a distressing medical event, your family deserves fair compensation. Our experienced team at TruLaw fights tirelessly for the rights of families in your situation and is personally invested in holding negligent entities responsible. To learn more about how we can support you during this time, reach out to our team or try out our free Instant Case Evaluation ℠.