Pacific Health Sciences is recalling one lot of its Magic Tea Brand Baby Sleep Gripe Water dietary supplement because the bottles may contain alcohol.
According to the FDA, testing of the affected lot identified ethanol, methanol and isopropanol that were not declared on the product label.
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The measured levels were approximately 8.3% ethanol, 0.35% methanol and 0.48% isopropanol. None of these substances were listed on the label.
The FDA says exposure to these ingredients may pose a risk to children.
Possible effects include drowsiness, loss of coordination, behavioral changes, nausea, vomiting and abdominal pain.
In larger amounts, exposure could increase the risk of respiratory depression and other serious health consequences.
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The recalled product is sold in amber bottles packaged inside a blue cardboard box and has a best-by date of December 2028.
Lot number: 25122BW
Consumers who have the recalled product should discard it or return it to the place of purchase for a refund.
