Replesta Children's FDA Alerts

Nordic Naturals Issues Voluntary Recall of Baby's Vitamin D3 Liquid Due to Elevated Levels of Vitamin D3

Watsonville, Calif. (Feb. 17, 2024) – Nordic Naturals is voluntarily recalling one lot of Nordic Naturals Baby’s Vitamin D3 Liquid, 0.76 fl. oz. (22.5 mL), 400 IU (10mcg) D3. This recall is being conducted due to a manufacturing error that resulted in an elevated level of Vitamin D3 dosage or super potent dose. The affected lot number is 234909, with an expiration date of December 2025.

Prolonged use of the recalled Baby’s Vitamin D3 Liquid could potentially lead to elevated vitamin D levels, resulting in vomiting, loss of appetite, increased thirst, frequent urination, and inability to thrive in infants.

Nordic Naturals has taken immediate action by notifying distributors, retailers and customers directly via email and arranging for the return of all recalled products. The affected product is used as a dietary supplement for infants up to 12 months of age and is packaged in boxes containing one bottle and one dropper for dosage, under SKU RUS-02733.

Consumers, distributors, and retailers in possession of the recalled product should discontinue use immediately and return it to the place of purchase for a refund or replacement. The lot number can be found on the back of the box and on the bottle.

Approximately 3,800 units of product were affected, with one-fifth already returned by retailers. The reason for the recall is solely due to an isolated manufacturing error. There have been no reports of adverse events to date related to the use of this recalled product.

If infants experience any of these symptoms while using the product, report them to the FDA's MedWatch Adverse Event Reporting program online at www.fda.gov/medwatch/report.htm. Nordic Naturals can also be contacted directly at customerservice@nordicnaturals.com or 888-294-7440, Monday – Friday, 8:00 a.m. - 5:00 p.m. PST. Consumers are advised to consult their physician or healthcare provider if they have experienced any problems related to taking or using this product.

Nordic Naturals prioritizes consumer safety, reaffirming its dedication to quality products. We are swiftly removing the recalled item from the market to safeguard the health and well-being of our customers.

Source: FDA

Vitamin D Supplement Products: Medication Use Error

Infant Overdose Risk With Liquid Vitamin D - FDA Consumer Update

ISSUE: Some liquid Vitamin D supplement products are sold with droppers that could allow parents to accidentally give harmful amounts of Vitamin D to their infant. Excessive amounts of Vitamin D can be harmful to infants, and may be characterized by nausea and vomiting, loss of appetite, excessive thirst, frequent urination, constipation, abdominal pain, muscle weakness, muscle and joint aches, confusion, and fatigue, as well as more serious consequences like kidney damage.

BACKGROUND: The American Academy of Pediatrics has recommended a dose of 400 International Units (IU) of Vitamin D Supplement per day to breast-fed and partially breast-fed infants (AAP Pediatric Nutrition Handbook, 6th edition, p.466).

RECOMMENDATION: The easiest way to insure that an infant will not get more than the recommended dose is to use a product supplied with a dropper that will give no more than 400 IU per dose. If a caregiver cannot clearly determine the dose of Vitamin D that should be given to an infant or has any other questions, FDA recommends consulting with a healthcare provider before giving any of these products to an infant.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: