RECALL: Perrigo Issues Voluntary Recall of One Batch of Premium Infant Formula with Iron Milk-Based Powder Due to Elevated Levels of Vitamin D

Please review the following recall below, check your inventory for affected products, and take necessary action.

 

Post this recall notice where those accessing your organization can see it (e.g., bulletin board, website, social media).

 

Let us know if you have any questions or concerns.

 

 

 

Company Announcement Date:

August 08, 2024

FDA Publish Date:

August 08, 2024

Product Type:

Food & Beverages
Infant Formula & Foods

Reason for Announcement:

Product contains levels of Vitamin D above the maximum level permitted

Company Name:

Perrigo Company plc

Brand Name:

CVS Health, H-E-B Baby

Product Description:

Premium Infant Formula with Iron Milk-Based Powder

Company Announcement

Dublin, Ireland and Allegan, MI – August 8, 2024 – Perrigo Company plc is issuing a voluntary recall at the retailer and warehouse level of three lots within one batch, or 16,500 cans, of store brand Premium Infant Formula with Iron Milk-Based Powder due to levels of Vitamin D above the maximum level permitted. 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, MO. No other products or retailers are impacted by this recall.

The Company is initiating this voluntary recall in consultation with the U.S. Food and Drug Administration (FDA). There have been no reports of adverse events to date attributed to the elevated levels of Vitamin D in the product subject to this recall, which was determined through routine testing.

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 (e.g., 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 below 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.

Perrigo has taken immediate action by notifying H-E-B Grocery Company, LP and CVS directly and asking them to examine their retail and warehouse inventory and isolate the product.

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)

No other lot codes are impacted by this recall.

If infants experience any symptoms while using the product, report them to the FDA’s MedWatch Adverse Event Reporting program online at www.fda.gov/medwatch/report.htm. Additionally, please contact your healthcare provider.

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, M-F from 8:00am-5:00pm EST.

Company Contact Information

Consumers:

Perrigo Consumer Affairs Contact Information

1-800-538-9543

 

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* We believe that none of the product being recalled were processed or offered through the national office
* We strongly encourage you to notify your agencies within one business day from receipt of this notice.
* ALL cased and uncased inventories, both at the member level and agency level, need to be checked. This product may have entered member and agency warehouses through salvage, local donations, TEFAP, local purchases, retail pickups, food drives, or other avenues.
* For additional local details, please contact the Health Department(s) for the area(s) your food bank serves.
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About Feeding America Recall Notices

The Feeding America national office issues notifications of all national Class I and II recalls–those involving a health hazard situation in which there is reasonable probability that eating the food will cause health problems or death–and other recalls that may affect the safety of food supplied to network members.

The national office strongly encourages all member product solicitors, operations managers, and others involved in food and grocery distribution to regularly consult resources provided by the United States Food and Drug Administration (FDA) at http://www.fda.gov/opacom/7alerts.html, and the United States Department of Agriculture (USDA) at http://www.fsis.usda.gov/Fsis_Recalls/index.asp. Additionally, members can often receive information on national, state, and local recalls by contacting their local health departments.

Feeding America National Office
Feeding America
161 N Clark, Suite 700
Chicago, IL 60601