Perrigo Conducts Recall of CVS Health and H-E-B Baby Premium Infant Formula

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Baby formula manufacturer, Perrigo, issued a voluntary recall due to high levels of vitamin D that were above the maximum level permitted.

FDA logo; image credit: fda

Image credit: FDA

Late last week, Perrigo announced it was conducting a voluntary recall of its Premium Infant Formula with Iron Milk-Based Powder, because of elevated levels of vitamin D that were above the maximum level allowed for these products.1

The recall includes at both the retailer and warehouse level that included three lots within one batch, or 16,500 cans, and the recalled product was shipped to H-E-B Grocery Company, LP in TX; and CVS in the following states: TX, FL, CA, SC, VA, IN, TN, NJ, MI, PA, RI, and MO. This recall impacted no other products or retailers.

Affected Products in the Recall

Product shipped to CVS beginning February 6, 2024, being recalled:

T11LMYC – USE BY 11NOV2025
(Material: 975261, UPC: 050428318034)

Product shipped to H-E-B Grocery Company, LP beginning February 2, 2024, being recalled:

T11LMXC – USE BY 11NOV2025
T09LMXC – USE BY 09NOV2025
(Material: 788362, UPC: 041220164578)

As of August 8, when the recall was announced, there had been no reports of adverse events attributed to the elevated levels of Vitamin D in the product subject to this recall. The high levels of vitamin D were discovered through routine testing.

According to the announcement on the FDA’s website, concerns are limited. For the vast majority of infants, short-term consumption of the affected lot codes is unlikely to cause adverse health implications. In a small subset of physiologically vulnerable infants (eg, impaired renal function), there is the potential that consumption of the recalled product could result in health complications.

Parents and caregivers who may have purchased the product should look for the lot codes listed on the right 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.

If any infants experience any symptoms while using the product, clinicians and parents can report them to the FDA's MedWatch Adverse Event Reporting program online at www.fda.gov/medwatch/report.htm. Additionally, it is advised to contact a healthcare provider if this happens.

Any questions or concerns regarding the recall or adverse events associated with these lot codes can be communicated to Perrigo Consumer Affairs at 1-800-538-9543, Monday to Friday, from 8:00 am to 5:00 pm EST.

For more information on the recall, interested parties can go to the FDA site.



Reference
1. Perrigo Issues Voluntary Recall of One Batch of Premium Infant Formula with Iron Milk-Based Powder Due to Elevated Levels of Vitamin D. FDA press release. August 8, 2024. August 12, 2024.
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/perrigo-issues-voluntary-recall-one-batch-premium-infant-formula-iron-milk-based-powder-due-elevated
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