Immediate Release – February 17, 2024
Product Information: Nordic Naturals is issuing a voluntary recall of the following product:
Product Name: Baby’s Vitamin D3 Liquid
Size: 0.76 fl. oz. (22.5 mL)
Dosage: 400 IU (10mcg) D3 per serving
Reason for Recall: Due to a manufacturing error, one lot of Nordic Naturals Baby’s Vitamin D3 Liquid has been found to contain elevated levels of Vitamin D3. Long-term consumption at these levels may lead to adverse health effects in infants, such as vomiting, loss of appetite, increased thirst, frequent urination, and lethargy. 1
Health Risks: Excessive intake of Vitamin D3 can impair infant growth and cause hyperkalemia, dehydration, and other serious health issues. Parents and caregivers are advised to monitor for symptoms and consult a healthcare professional if concerns arise.
Regulatory Actions:
In line with FDA regulations, Nordic Naturals is proactively recalling the affected product from the market.
Consumers in possession of the recalled product should cease use immediately and can return it to their place of purchase for a full refund or exchange.
The FDA encourages consumers to report any adverse reactions through the FDA’s MedWatch Adverse Event Reporting program.
Safety Reminder: The current tolerable upper intake level for Vitamin D3 in infants (0 to 6 months) is set at 400 IU/day. This incident underscores the importance of adhering to recommended dosages for vitamin supplements. 2
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References
[2] https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=172.380