The Food and Drug Administration (FDA) has updated its risk classification for the recall of Perrigo’s Premium Infant Formula with Iron Milk-Based Powder, assigning it a Class II designation. This update follows concerns that the formula contains elevated levels of Vitamin D, exceeding the maximum permitted amount.

Key Details:

• Recall Date: August 8, 2024
• FDA Classification: Class II
  • This classification indicates that exposure to the product may cause temporary or medically reversible adverse health consequences, with the probability of serious adverse effects being remote.
• Affected Units: 16,500 units
• Distribution States: Texas, Florida, California, South Carolina, Virginia, Indiana, Tennessee, New Jersey, Michigan, Pennsylvania, Rhode Island, Missouri
• Retail Outlets: H-E-B Grocery Company (Texas), CVS stores

Reason for Recall:

Elevated Vitamin D levels were detected during routine testing. Although no adverse events have been reported, the FDA advises caution. The recall affects formula distributed across 12 states, with concerns primarily for a small subset of infants who may have underlying health conditions.

Health Advisory:

• For Most Infants: Short-term consumption of the affected formula is unlikely to result in significant health issues.
• For Vulnerable Infants: Infants with impaired renal function or other physiological vulnerabilities could face potential health complications due to the elevated Vitamin D levels.

Next Steps for Consumers:

• Product Identification: Check for affected lot codes on the packaging.
• Action Required: Parents and caregivers should discontinue use of the recalled formula and consult healthcare providers if their child has consumed it or if they have any health concerns.
• Refund and Replacement: Contact the point of purchase or Perrigo for instructions on returning the product and obtaining a refund or replacement.

FDA Statement:

The FDA continues to monitor the situation and advises consumers to stay informed through updates. For further information and a list of affected lot codes, please visit the FDA website or contact Perrigo directly.

Stay vigilant and ensure the safety of your infants by adhering to recall instructions and seeking medical advice if necessary.